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™ 1 mL Insulin Safety Syringe Permanent Needle 31G x 15/64'' (0.25 x 6 mm) FDA UDI
Model / Reference: 8881893110 FDA UDI
Description: Monoject™ Magellan™ 1 mL Insulin Safety Syringe Permanent Needle 31G x 15/64'' (0.25 x 6 mm) FDA UDI

Identifiers

Catalog Number: 8881893110 FDA UDI
Primary DI / UDI-DI: 10885380184703 FDA UDI
FDA Product Code: FMI FDA UDI
MEG FDA UDI
FMF FDA UDI
GMDN Term: Insulin syringe/needle, safety FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5570 FDA UDI
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 — 1 Milliliter FDA UDI
Length — 6 Millimeter FDA UDI
Needle Gauge — 31 Gauge 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.

SecureSafe Syringe With Safety Needle — Dynarex Corp. · Class II
McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
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

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

Manufacturer

Manufacturer: Cardinal Health 200, LLC

Sources (1)

FDA UDI c84152c7-e22e-4d65-bd57-1b220b9af8a1 35 fields · synced Jun 8, 2026