Monoject

FDA UDI

Class II (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name: Monoject FDA UDI
Generic Name: Catheter injection port FDA UDI
Device Name: Intermittent Infusion Plug Standard FDA UDI
Model / Reference: 8888115006 FDA UDI
Description: Intermittent Infusion Plug Standard FDA UDI

Identifiers

Catalog Number: 8888115006 FDA UDI
Primary DI / UDI-DI: 10192253003352 FDA UDI
FDA Product Code: FPK FDA UDI
GMDN Term: Catheter injection port FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5440 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Catheter injection port

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

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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 65027b6d-916e-496b-a93f-93aaf441670a 34 fields · synced Jun 8, 2026