Invacare® Platinum® Mobile Oxygen Concentrator with 2nd Battery

FDA UDI

Class II (US FDA UDI)

by Invacare Corp.

Identity

Trade Name: Invacare® Platinum® Mobile Oxygen Concentrator with 2nd Battery FDA UDI
Generic Name: Mobile/portable oxygen concentrator FDA UDI
Device Name: Invacare POC1-100BA Platinum Mobile Oxygen Concentrator + 2Nd Battery FDA UDI
Model / Reference: POC1-100BAAMZ FDA UDI
Description: Invacare POC1-100BA Platinum Mobile Oxygen Concentrator + 2Nd Battery FDA UDI

Identifiers

Catalog Number: POC1-100BAAMZ FDA UDI
Primary DI / UDI-DI: 00841447103394 FDA UDI
510(k) Number: K160630 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Mobile/portable oxygen concentrator

Invacare® Platinum® Mobile Oxygen Concentrator with 2nd Battery by Invacare Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K160630 also covers:

Invacare® Platinum® Mobile Oxygen Concentrator 12V DC Power Cable — Invacare Corp.

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: Invacare Corp.

Sources (1)

FDA UDI 72924634-dccf-42d7-a5e8-2784cfeccb26 36 fields · synced May 29, 2026