Oxygen Concentrator

FDA UDI

Class II (US FDA UDI)

by Proactive Medical Products

Identity

Trade Name: Oxygen Concentrator FDA UDI
Generic Name: Stationary oxygen concentrator FDA UDI
Device Name: Oxygen Concentrator, 5 Litre FDA UDI
Model / Reference: PMCON5L FDA UDI
Description: Oxygen Concentrator, 5 Litre FDA UDI

Identifiers

Catalog Number: PMCON5L FDA UDI
Primary DI / UDI-DI: 05060488571671 FDA UDI
510(k) Number: K090007 FDA UDI
FDA Product Code: CAW FDA UDI
GMDN Term: Stationary 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Height — 22 Inch FDA UDI
Width — 13 Inch FDA UDI
Length — 11 Inch FDA UDI

Category: Stationary oxygen concentrator

Oxygen Concentrator by Proactive Medical Products — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary oxygen concentrator.

MARK 5 NUVO LITE — Nidek Medical Products Inc. · Class II
NewLife Elite — Airsep Corp. · Class II
OxyHome — Mv Life LLC · Class II
NewLife Intensity 10 — CAIRE INC. · Class II
konsung — Jiangsu Konsung Bio Medical Science and Technology Co., Ltd. · Class II
NewLife Intensity — Airsep Corp. · Class II
DeVilbiss — DeVilbiss Healthcare LLC. · Class II
Inogen At Home Stationary Concentrator — Inogen, Inc. · Class II

Cleared under the same submission

K090007 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: Proactive Medical Products

Sources (1)

FDA UDI fc9f1906-62ce-4982-930b-0f325e48487e 37 fields · synced Jun 8, 2026