HEPRO.US - Syringe 1ml/cc 28G x 1/2"

FDA UDI

Class II (US FDA UDI)

by Hepro.us Inc.

Identity

Trade Name: HEPRO.US - Syringe 1ml/cc 28G x 1/2" FDA UDI
Generic Name: Insulin syringe/needle, basic FDA UDI
Device Name: Insulin Syringes with Permanent Needle 1ml/cc x 28G x 1/2" Single FDA UDI
Model / Reference: SINGLE - 1ml/cc 28G x 1/2" FDA UDI
Description: Insulin Syringes with Permanent Needle 1ml/cc x 28G x 1/2" Single FDA UDI

Identifiers

Primary DI / UDI-DI: 00854427007698 FDA UDI
FDA Product Code: FMF FDA UDI
GMDN Term: Insulin syringe/needle, basic 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Insulin syringe/needle, basic

HEPRO.US - Syringe 1ml/cc 28G x 1/2" by Hepro.us Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Insulin syringe/needle, basic.

EasyTouch — MHC Medical Products · Class II
EasyTouch — MHC Medical Products · Class II
BH Supplies — ANREL DISTRIBUTION LLC · Class II
BD Ultra-Fine — BECTON DICKINSON AND COMPANY · Class II
droplet insulin syringes — HTL STREFA S A · Class II
Insulin Syringe — Dynarex Corp. · Class II
LiteTouch — AMITY HOLDINGS, LLC · Class II
Ultra-Care Insulin Syringe 30G 5/16" 0.5 CC 100 Ct — ARISE MEDICAL LLC · 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: Hepro.us Inc.

Sources (1)

FDA UDI f4020075-e471-4d90-9c36-d8d8ed81d074 33 fields · synced Jun 8, 2026