McKesson

FDA UDI

Class II (US FDA UDI)

by Mckesson Medical-Surgical Inc.

Identity

Trade Name: McKesson FDA UDI
Generic Name: Catheter injection port FDA UDI
Device Name: IV CATH 22X1 FDA UDI
Model / Reference: 6048 FDA UDI
Description: IV CATH 22X1 FDA UDI

Identifiers

Primary DI / UDI-DI: 10612479212562 FDA UDI
510(k) Number: K071382 FDA UDI
FDA Product Code: FOZ FDA UDI
GMDN Term: Catheter injection port FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5200 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

Category: Catheter injection port

McKesson by Mckesson Medical-Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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175IBLSSC — ELCAM MEDICAL ITALY SPA · Class I
Argyle — Mozarc Medical US LLC · Class II
VERSCHLUSSKAPPE — Pajunk GmbH Medizintechnologie · Class II
Injection Tube, LL male/LL female — Pajunk GmbH Medizintechnologie · Class II

Cleared under the same submission

K071382 also covers:

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: Mckesson Medical-Surgical Inc.

Sources (1)

FDA UDI c08a506f-89e6-4848-bb1f-773176845a3b 34 fields · synced May 30, 2026