Patient Safe®

FDA UDI

Class II (US FDA UDI)

by Retractable Technologies, Inc.

Identity

Trade Name: Patient Safe® FDA UDI
Generic Name: General-purpose syringe, single-use FDA UDI
Device Name: 20mL Patient Safe® Syringe FDA UDI
Model / Reference: 52001 FDA UDI
Description: 20mL Patient Safe® Syringe FDA UDI

Identifiers

Catalog Number: 52001 FDA UDI
Primary DI / UDI-DI: 00613703520005 FDA UDI
510(k) Number: K072654 FDA UDI
FDA Product Code: FMF FDA UDI
GMDN Term: General-purpose syringe, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5860 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: General-purpose syringe, single-use

Patient Safe® by Retractable Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose syringe, single-use.

Merit Medical® — Merit Medical Systems, Inc. · Class II
SOFT-JECT® — Henke-Sass, Wolf GmbH · Class II
CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
SURGYCO — Surgyco LLC · Class I
NAMIC — MEDLINE INDUSTRIES, INC. · Class II
HSW HENKE-JECT® — Henke-Sass, Wolf GmbH · Class II
BD Safety-Lok — BECTON DICKINSON AND COMPANY · Class II
SURGYCO — Surgyco LLC · Class I

Cleared under the same submission

K072654 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Retractable Technologies, Inc.

Sources (1)

FDA UDI fc1039fe-95f3-4417-a5a7-7d1c8d0e13b5 36 fields · synced Jun 8, 2026