← Product Code [MEG](/productcode/MEG) · K933469

# UNIVEC NON-REUSABLE SYRINGE (K933469)

_Univec, Inc. · MEG · Apr 18, 1996 · General Hospital · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K933469

## Device Facts

- **Applicant:** Univec, Inc.
- **Product Code:** [MEG](/productcode/MEG.md)
- **Decision Date:** Apr 18, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5860
- **Device Class:** Class 2
- **Review Panel:** General Hospital
- **Attributes:** Therapeutic

## Indications for Use

This syringe is intended for diabetics who inject insulin and healthcare professionals who inject insulin, tuberculin or immunization serum and other injectible medications.

## Device Story

Sterile polypropylene piston syringe; 1 cc or 0.5 cc capacity; features 'umbrella' locking mechanism. Used by diabetics or healthcare professionals for aspiration, mixing, and injection of medications. Locking mechanism activated by depressing plunger past resistance point; prevents syringe reuse. Device functions as standard syringe until locked; provides safety benefit by rendering device non-reusable post-injection.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Polypropylene construction; piston syringe design; manual operation; 1 cc or 0.5 cc capacity; non-reusable locking mechanism; sterile.

## Regulatory Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

## Predicate Devices

- UNIVEC Nonreusable Locking Syringe ([K943679](/device/K943679.md))
- FLP Enterprises LOKSHOT Syringe ([K891467](/device/K891467.md))

## Submission Summary (Full Text)

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K933469

# SUMMARY OF SAFETY AND EFFECTIVENESS OF UNIVEC NONREFUSABLE LOCKING SYRINGE

(1) Submitter’s Information:

UNIVEC, Inc.
999 Franklin Avenue
Garden City, New York 11530
(516) 294-1000 (tel)
(516) 739-3343 (fax)

(2) Device Name:

Proprietary Name: Model 884 Umbrella Nonreusable Syringe
Common or Usual Name: Piston, Hypodermic Needle
Classification Names: Piston Syringe
21 C.F.R. 880.5860 Class II
Hypodermic Single Lumen Needle
21 C.F.R. 880.5570 Class II

(3) Predicate Devices:

UNIVEC Nonreusable Locking Syringe (K943679)
FLP Enterprises LOKSHOT Syringe (K891467)

(4) Description of Device:

The UNIVEC Model 884 Umbrella Nonreusable Syringe is a sterile piston syringe with 1 cc or 0.5 cc capacities fabricated of polypropylene. It has a locking device made of the same polypropylene material. The “umbrella” description describes the locking mechanism which emulates the shape and functioning of an umbrella.

Functioning in the traditional manner, this syringe is capable of aspirating and mixing various serums in its barrel by health practitioners and individuals for subsequent injection. It can be locked or prevented from further use by depressing the plunger toward the forward end of the barrel (and past noticeable resistance) in order to activate the locking device. Further use of the syringe is thus prevented.

(5) Statement of Intended Use

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This syringe is intended for diabetics who inject insulin and healthcare professionals who inject insulin, tuberculin or immunization serum and other injectible medications.

## (6) Statement of Technological Characteristics

The UNIVEC Nonreusable Syringe has no significant change in design, material, chemical composition, energy source or other characteristics compared to the predicate devices listed. The locking device, fabricated of polypropylene, the same material as the rest of the syringe, is the only difference with one of the predicates, the UNIVEC Model 888 Nonreusable Locking Syringe (K943679), (its locking device is made from stainless steel 304). There are no differences with the FLP Enterprises LOKSHOT Syringe, # K891467

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**Source:** [https://fda-staging.innolitics.com/device/K933469](https://fda-staging.innolitics.com/device/K933469)

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