McKesson

FDA UDI

Class II (US FDA UDI)

by Mckesson Medical-Surgical Inc.

Identity

Trade Name: McKesson FDA UDI
Generic Name: Mobile/portable oxygen concentrator FDA UDI
Device Name: CONCENTRATOR, OXYGEN 5LTR W/OXY SENSOR FDA UDI
Model / Reference: 146-525DS FDA UDI
Description: CONCENTRATOR, OXYGEN 5LTR W/OXY SENSOR FDA UDI

Identifiers

Primary DI / UDI-DI: 10612479248158 FDA UDI
510(k) Number: K071397 FDA UDI
FDA Product Code: CAW FDA UDI
GMDN Term: Mobile/portable oxygen concentrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5440 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Mobile/portable oxygen concentrator

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

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Cleared under the same submission

K071397 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 3d811df9-3463-4727-9af0-df7bc1358aec 34 fields · synced Jun 1, 2026