Merit Medical®

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name: Merit Medical® FDA UDI
Generic Name: General-purpose syringe, single-use FDA UDI
Model / Reference: 00884450151938 FDA UDI

Identifiers

Catalog Number: K02-01419 FDA UDI
Primary DI / UDI-DI: 00884450151938 FDA UDI
FDA Product Code: OEQ FDA UDI
GMDN Term: General-purpose syringe, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1650 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: General-purpose syringe, single-use

Merit Medical's General-purpose syringe, single-use device designed for various medical applications. This sterile syringe is intended for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body. Its distal end features a male connector (typically Luer-lock/slip type) for attachment to a hypodermic needle or an administration set.

Similar devices

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

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
KBMED — KB Medical (group), Inc. · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Merit Medical Systems, Inc.

Sources (1)

FDA UDI a2592ea3-f52d-437b-8f9e-01f1c62294b0 33 fields · synced Jul 27, 2026