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Monoject

FDA UDI

Class II (US FDA UDI)

by Cardinalhealth

Identity

Trade Name
Monoject FDA UDI
Generic Name
Parenteral/enteral solution bag FDA UDI
Device Name
Tamper Evident Syringe Bag FDA UDI
Model / Reference
46312 FDA UDI
Description
Tamper Evident Syringe Bag FDA UDI

Identifiers

Catalog Number
46312 FDA UDI
Primary DI / UDI-DI
10884521544468 FDA UDI
FDA Product Code
PNR FDA UDI
GMDN Term
Parenteral/enteral solution bag FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5980 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Parenteral/enteral solution bag

Monoject by Cardinalhealth — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Parenteral/enteral solution bag.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinalhealth

Sources (1)

  • FDA UDI 5ef1caf0-7ce3-44bc-8e26-f81efce74d86 36 fields · synced May 30, 2026