Monoject

FDA UDI

Class II (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name: Monoject FDA UDI
Generic Name: Tuberculin/allergy syringe/needle, safety FDA UDI
Device Name: 0.5 mL Allergy Tray Permanent Needle FDA UDI
Model / Reference: 8881500501 FDA UDI
Description: 0.5 mL Allergy Tray Permanent Needle FDA UDI

Identifiers

Catalog Number: 8881500501 FDA UDI
Primary DI / UDI-DI: 10884521013926 FDA UDI
FDA Product Code: FMF FDA UDI
GMDN Term: Tuberculin/allergy syringe/needle, safety 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

Yes

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

FDA UDI

Dimensions & Sizes

Size: Total Volume — 0.50 Milliliter FDA UDI
Needle Gauge — 28 Gauge FDA UDI

Category: Tuberculin/allergy syringe/needle, safety

Monoject by Cardinal Health 200, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tuberculin/allergy syringe/needle, safety.

HEPRO.US - Tuberculin Syringe attached needle, 1ml/cc 25G x 5/8" — HEPRO.US INC. · Class II
Monoject — Cardinalhealth · Class II
Monoject — Cardinalhealth · Class II
Monoject — Cardinalhealth · Class II
Monoject — Cardinalhealth · Class II
Monoject — Cardinalhealth · Class II
Monoject — Cardinalhealth · Class II
HEPRO.US - Tuberculin Syringes - 1ml/cc 25G x 5/8" — HEPRO.US 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

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Manufacturer

Manufacturer: Cardinal Health 200, LLC

Sources (1)

FDA UDI e5af721e-4c86-4208-824e-c2fd837b9743 36 fields · synced Jun 8, 2026