Who is the manufacturer of 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub?

Becton, Dickinson and Company filed the 510(k) submission for 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub (K213955).

What is the FDA product code for 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub?

QTI. It is classified under 21 CFR 880.5200 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub?

510(k) clearance (submission type: Traditional).

What are the predicate devices for 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub?

0.9% Sodium Chloride Injection, USP BD PosiFlush™ SP Syringe (K161552); SiteScrub IPA Device (K112791).

Who can help prepare an FDA 510(k) submission like 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub

K213955 · Becton, Dickinson and Company · QTI · Jul 16, 2022 · General Hospital

Device Facts

Record ID	K213955
Device Name	0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub
Applicant	Becton, Dickinson and Company
Product Code	QTI · General Hospital
Decision Date	Jul 16, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5200
Device Class	Class 2

Indications for Use

The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SafeScrub prefilled flush syringe with an integrated disinfection unit is intended to be used as a disinfection cleaner for needleless access devices attached to indwelling vascular access devices (VADs) and flushing of these VADs.

Device Story

BD PosiFlush SafeScrub is a sterile, single-use, pre-filled 10mL saline syringe with an integrated disinfection unit (DU). The device combines a 0.9% sodium chloride flush syringe with a disinfection cap containing 70% isopropyl alcohol (IPA) in a foam insert. Used by clinicians in clinical settings to disinfect needleless access devices (injection ports/female Luer hubs) and flush indwelling vascular access devices. The DU is snapped onto the modified syringe tip cap. Operation involves mechanical friction and chemical disinfection (IPA) via twisting the DU on the access device. The device ensures sterile fluid path maintenance and catheter patency; benefits include reduced risk of catheter-related bloodstream infections through standardized disinfection and flushing.

Clinical Evidence

Bench testing only. Testing included container closure integrity, leakage, torque removal, axial pull force, particulate ingress (USP <788>), antimicrobial efficacy (≥4-log reduction), IPA concentration, foam durability/retention, IPA ingress, and packaging integrity. Biocompatibility testing included cytotoxicity (ISO 10993-5), sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, hemocompatibility (ISO 10993-4/ASTM F756), and endotoxin testing (USP <161>).

Technological Characteristics

Materials: Polypropylene (barrel, plunger, tip cap), styrene-butadiene rubber (stopper), silicone (lubricant), HDPE (DU housing), LDPE (foam). Energy: Manual operation. Connectivity: None. Sterilization: Moist heat (syringe), gamma irradiation (DU). Form factor: 10mL syringe with integrated DU. Standards: ISO 10993-1, ISO 11607-1:2019, USP <788>, USP <161>.

Indications for Use

Indicated for use as a disinfection cleaner for needleless access devices (e.g., needlefree connectors, Y-sites, stopcocks) attached to indwelling vascular access devices and for flushing said VADs.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

0.9% Sodium Chloride Injection, USP BD PosiFlush™ SP Syringe (K161552)
SiteScrub IPA Device (K112791)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 16, 2022 Becton, Dickinson and Company Samhitha Mohan Staff Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417 Re: K213955 Trade/Device Name: BD PosiFlush SafeScrub Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: OTI Dated: June 29, 2022 Received: July 1, 2022 Dear Samhitha Mohan: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Bifeng Oian, M.D., Ph.D Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K213955 Device Name BD PosiFlush™ SafeScrub Indications for Use (Describe) The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SafeScrub prefilled flush syringe with an integrated disinfection unit is intended to be used as a disinfection cleaner for needleless access devices attached to indwelling vascular access devices (VADs) and flushing of these VADs. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------| | <div> X Prescription Use (Part 21 CFR 801 Subpart D) </div> | Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the BD logo. The logo consists of an orange circle with a stylized sunburst design inside, followed by the letters "BD" in blue. The sunburst design has a central circle with radiating lines, and the letters "BD" are in a bold, sans-serif font. # BD PosiFlush™ SafeScrub - K213955 # 510(k) Summary (21 CFR §807.92) | Submitter Information | Submitter Name: Submitter Address: Contact Person: Email Address: Phone Number: Fax Number: 510(k) Number: Date of Preparation: | Becton, Dickinson and Company 1 Becton Drive Franklin Lakes NJ 07417 Samhitha Mohan Staff Regulatory Affairs Specialist Samhitha.Mohan@bd.com (214) 971-0979 (201) 847-5307 K213955 July 15, 2022 | |---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Subject Device | Trade Name: Common Name: Regulation Number: Device Class: Classification Name: Classification Product Code: Classification Panel: | BD PosiFlush™ SafeScrub Pre-filled Saline Syringe with Disinfection Unit 21 CFR 880.5200 Class II Saline, Vascular Access Flush QTI General Hospital | | Primary Predicate Device | Trade Name: | 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SP Syringe | | | 510(k) Number: Classification Name: Regulation Number: Regulatory Class: Product Code: Classification Panel: | K161552 Saline, Vascular Access Flush 21 CFR 880.5200 Class II NGT General Hospital | | Predicate Device | Trade Name: 510(k) Number: Classification Name: Regulation Number: Regulatory Class: Product Code: Classification Panel: | SiteScrub IPA Device K112791 Pad, Alcohol, Device Disinfectant Unclassified Unclassified LKB General Hospital | | Device Description | BD PosiFlush™ SafeScrub is a sterile, single use pre-filled saline syringe with integrated Disinfection Unit (DU). The polypropylene syringe contains 0.9% sodium chloride (USP) solution with a tip cap that is modified at the distal end to accommodate DU. The DU has high density polyethylene housing with 70% Isopropyl Alcohol (IPA) solution in low density polyethylene foam. The pre-filled syringe with modified syringe tip cap is sterilized by moist heat and the DU is sterilized by gamma irradiation. The subject device is available only in 10mL syringe configuration. | | | Indications for Use | The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SafeScrub prefilled flush syringe with an integrated disinfection unit is intended to be used as a disinfection cleaner for needleless access devices attached to indwelling vascular access devices (VADs) and flushing of these VADs. | | | Technological Characteristic- s | | The following table provides a comparison between the subject and predicate devices – | {4}------------------------------------------------ {5}------------------------------------------------ | Attribute | Subject Device (BD PosiFlush™ SafeScrub) | Primary Predicate Device (0.9% Sodium Chloride Injection, USP BD PosiFlush™ SP Syringe) – K161552 | Predicate Device (SiteScrub IPA Device) – K112791 | Comparison | |--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use/Indications for Use | The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SafeScrub prefilled flush syringe with an integrated disinfection unit is intended to be used as a disinfection cleaner for needleless access devices attached to indwelling vascular access devices (VADs) and flushing of these VADs. | The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe is intended to be used only for the flushing of indwelling vascular access devices. Catalog Number 306547 10 mL BD PosiFlush™ SP Syringes are generally compatible for use with syringe pumps. | The Site-Scrub IPA Device is intended for use on injection ports and female Luer hubs as a disinfecting cleaner. | The intended use of the subject device is created by combining the intended use of both the predicates. The subject device's intended use does not include pump compatible statement since PosiFlush™ SafeScrub is not intended to be used with pumps. Additionally, subject device's intended use refers to injection ports and female Luer hubs as needleless access devices. | | Operating Principle | Same as predicates | The pre-filled USP 0.9% saline syringe flushes indwelling vascular access devices | 70% IPA solution i.e., antimicrobial agent and active mechanical friction from the foam aids in disinfection | Identical | | Disinfectio -n Time | Same as predicate | N/A | Twist back and forth for at least 8 repetitions, for a minimum of 10 seconds | Identical | | Target microorga nisms for in vitro antimicrob -ial efficacy | • Staphylococcus aureus • Staphylococcus epidermidis • Escherichia coli • Pseudomonas aeruginosa • Candida albicans • Candida glabrata • Acinetobacter baumannii | N/A | • Staphylococcus aureus • Staphylococcus epidermidis • Escherichia coli • Pseudomonas aeruginosa • Candida albicans • Candida parapsilosis | Identical except for Acinetobacter baumannii, Candida glabrata and Candida parapsilosis. In vitro antimicrobial efficacy testing was performed for all the microorganisms | | Syringe Configura- tion | 10mL only | 3mL, 5mL and 10mL | N/A | Subject device does not include 3 and 5mL syringe configurations | | Device Compone- nts | • Barrel • 0.9% NaCl solution • Plunger Rod • Modified Tip Cap • Stopper Lubricant • Stopper • Modified Housing • Foam • 70% IPA solution | • Barrel • 0.9% NaCl solution • Plunger Rod • Tip Cap • Stopper Lubricant • Stopper | • Housing • Foam • 70% IPA solution | All the components are identical in design with the exception of tip cap and housing. The distal end of tip cap and DU housing are modified to snap fit with each other to form PosiFlush™ SafeScrub | | Barrel Material | Same as predicate | Polypropylene | N/A | Identical | | Plunger Rod Material | Same as predicate | Polypropylene | N/A | Identical | | Stopper Material | Same as predicate | Styrenebutadiene rubber | N/A | Identical | | Stopper Lubricant Material | Same as predicate | Silicone | N/A | Identical | | Tip Cap Material | Same as predicate | Polypropylene w/ White Colorant | N/A | Identical | | DU Housing Material | Same as predicate w/white colorant | N/A | High Density Polyethylene (HDPE) w/blue colorant | HDPE material in DU is identical to SiteScrub's housing material. The subject device's DU has white colorant to match with the color of the tip cap. Colorant differences are assessed as per ISO 10993-1 | | Foam Material | Same as predicate | N/A | Low Density Polyethylene (LDPE) | Identical | | Foam Base Colorant | Same as predicate | N/A | Copper phthalocyanine blue | Identical | | Packaging Configurat ion | Same as predicates | • Flow wrap • Shelf Carton • Case Carton | Top Foil | Identical with the exception of top foil material. Appropriate packaging tests are performed to ensure top foil maintains sterile barrier to the DU | | Sterilizatio -n Mode | Same as predicates | Moist heat | Gamma | Identical | | SAL | Same as predicates | 10-6 (Sterile Fluid Path) | 10-6 (Sterile Fluid Path) | Identical | | Shelf Life | 0.5 years | 3 years | 9 months | Subject device shelf life has been assessed by appropriate bench performance testing | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ ### Discussion: The subject device and predicate devices are different with respect to the following items: - 1. The intended use of the subject device is identical to the predicates with the exception of pump compatibility statement since PosiFlush™ SafeScrub is not intended to be used with infusion pumps. The subject device refers to injection ports and female Luer hubs as needleless access devices. Needleless access devices include needlefree connector, Y-sites, and stopcocks. - 2. PosiFlush™ SafeScrub is created by combining the predicate devices (K161552 and K112791). The distal end of tip cap of PosiFlush SP syringe (K161552) and the housing of SiteScrub IPA Device (K112791) are dimensionally modified to integrate such that they remain attached to each other at all times. This integration/interface is evaluated by torque rotation and axial pull force tests throughout the shelf life. NOTE: The modified SiteScrub IPA Device in PosiFlush™ SafeScrub is referred as Disinfection Unit (DU). {9}------------------------------------------------ - 3. The microorganisms targeted by DU in the in vitro antimicrobial efficacy test were chosen based on the current literature search for microorqanisms that cause catheter related bloodstream infection. - 4. The material of top foil which creates a seal on the DU housing has been updated from the SiteScrub IPA Device to comply with ISO 11607-1:2019 and for vendor consolidation purposes. Similar to the predicate device, the new top foil material also ensures that it retains sterile barrier integrity and accordingly packaging tests such as vacuum bubble leak test, peel force test, seal width, visual inspection, and porosity tests are performed. - 5. Since the colorant of DU housing is changed from blue to white, appropriate biocompatibility tests are performed as per ISO 10993-1 to ensure the safe use of PosiFlush™ SafeScrub. The biocompatibility tests performed on the DU are identified below. The colorant was changed from blue to white to match with the color of tip cap. - 6. The subject device is also evaluated throughout its shelf life by bench performance testing to ensure that the device meets the predetermined acceptance criteria. The different technological characteristics between the subject and predicate device are evaluated in bench performance testing, in vitro antimicrobial efficacy, packaging integrity, and biocompatibility tests demonstrating that the different technological characteristics do not raise any new or different questions of safety and effectiveness. | Test | Purpose | Acceptance Criteria | Result | | |----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------| | Performance/Design Verification Tests | | | | | | Container Closure Integrity | Evaluate sterile barrier system for the syringe | No dye within the syringe | Pass | | | Leakage Test | Evaluate sterile barrier system for the syringe | No leakage from the syringe | Pass | | | | | | | | | Torque Removal Test | Evaluate tip cap removal | Tip Cap can be twisted off as per BD validated force | Pass | | | Sterile Fluid Path | Evaluate the syringe's fluid path sterility | SAL: 10-6 | Pass | | | Axial Pull Force | Evaluate the potential separation | DU cannot be pulled off per BD validated force | Pass | | | Torque | of Tip Cap from Disinfecting Unit (DU) | DU cannot be twisted off as per BD validated force | Pass | | | Particulate Ingress | Evaluate per USP <788> | USP <788> | Pass | | | Antimicrobial Efficacy | Evaluate disinfection efficacy of the DU | ≥ 4-log reduction | Pass | | | 70% IPA Concentrat- ion | Evaluate IPA concentration over shelf life for the DU | 70±7% | Pass | | | Foam Rotation | Evaluate foam rotation during use | Foam should not rotate >90 degrees within the DU housing during use | Pass | | | Foam | Evaluate foam retention before and during use | Foam must be retained within the DU | Pass | | | Retention | Evaluate foam retention after use | Foam must be retained within DU after scrubbing | Pass | | | Foam Durability | Evaluate foam for evidence of ripped or ragged material and debris or particulate | No ripped or ragged material and debris or particulate | Pass | | | Foam Compressibili | Evaluate foam for wetness and compressibility | Foam must be wet and compressible | Pass | | | | ty and Wetness | | | | | | 70% IPA Ingress | Evaluate IPA ingress that may enter the patient IV line | Maximum dose of 2 mg IPA/kg body mass/day per US EPA | Pass | | | Package integrity of DU | Evaluate sterile barrier system of the DU | Bubble Leak as per ASTM F2096 | Pass | | | | | Seal Width $\geq$ 0.58 mm | Pass | | | | | No delamination | Pass | | | | | Peel Force shall be within: USL: $\leq$ 12.9 N LSL: $\geq$ 3.69 N | Pass | | | | | Microbial properties as per ISO 11607-1:2019 | Pass | | | Biocompatibility | | | | | | Cytotoxicity | ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Grade $\leq$ 2 | Pass | | | Sensitization | ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Non-Sensitizer | Pass | | Irritation or Intracutaneo us Activity | ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Final Test Sample Score $\le$ 1 | Pass | | | Acute Systemic Toxicity | ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity | No significantly greater biological reaction than the control | Pass | | | Material Mediated Pyrogenicity | ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | No temperature rise $\ge$ 0.5° C | Pass | | | Hemocompat ibility | ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood | $\le$ 5% hemolysis | Pass | | | | ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials | | | | | LAL Endotoxin | USP 43-NF38 <161> Medical Devices - Bacterial Endotoxin | Below the Endotoxin Limit 20 EU/device | Pass | | | Extractable and Leachable Analysis | ISO 10993-18:2020 Biological evaluation of medical devices - Part 18: Chemical characterization of materials | N/A | Toxicolo- gical Risk Assessm- ent | | {10}------------------------------------------------ {11}------------------------------------------------ {12}------------------------------------------------ The 2 main components of BD PosiFlush™ SafeScrub are sterilized as follows: - 1. Pre-filled saline syringe with modified syringe tip cap is sterilized by moist heat {13}------------------------------------------------ | Clinical Testing | Not applicable. | |------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Conclusion | The BD PosiFlush™ SafeScrub is as safe and as effective and performs as well as or better than the legally marketed devices, 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe and SiteScrub IPA Device. | | | 2. DU is sterilized by gamma irradiation The subject device met all the predetermined acceptance criteria for the above listed performance tests. |

0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub

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0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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Special Control Matches

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