Monoject

FDA UDI

Class II (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name: Monoject FDA UDI
Generic Name: Insulin syringe/needle, safety FDA UDI
Device Name: Monoject™ Magellan™ 0.5 mL Insulin Safety Syringe Permanent Needle 31G x 15/64'' (0.25 x 6 mm) FDA UDI
Model / Reference: 8881893150 FDA UDI
Description: Monoject™ Magellan™ 0.5 mL Insulin Safety Syringe Permanent Needle 31G x 15/64'' (0.25 x 6 mm) FDA UDI

Identifiers

Catalog Number: 8881893150 FDA UDI
Primary DI / UDI-DI: 10885380184994 FDA UDI
FDA Product Code: FMF FDA UDI
MEG FDA UDI
FMI FDA UDI
GMDN Term: Insulin syringe/needle, safety FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5860 FDA UDI
880.5570 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: Length — 6 Millimeter FDA UDI
Needle Gauge — 31 Gauge FDA UDI
Total Volume — 0.5 Milliliter FDA UDI

Category: Insulin 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 Insulin syringe/needle, safety.

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RELI — MYCO MEDICAL SUPPLIES INC. · Class II
ONE-CARE Safety Pen Needles 30G x 8mm, Yellow, — MediVena, LLC · Class II
Endure — ENDURE INDUSTRIES, INC. · Class II
McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
Disposable Insulin Syringe — Berpu Medical Technology Co., Ltd · Class II
RELI — MYCO MEDICAL SUPPLIES 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 e4921741-5228-41ad-9db0-39f10e9ab7fa 35 fields · synced Jun 8, 2026