Mill, 10 Lpm, Conc Canadian

FDA UDI

Class II (US FDA UDI)

by Respironics, Inc.

Identity

Trade Name: MILL,10 LPM,CONC CANADIAN FDA UDI
Generic Name: Stationary oxygen concentrator FDA UDI
Device Name: Millennium M10 Concentrator, Canada FDA UDI
Model / Reference: Millennium M10 Concentrator, CA FDA UDI
Description: Millennium M10 Concentrator, Canada FDA UDI

Identifiers

Catalog Number: M10600-80 FDA UDI
Primary DI / UDI-DI: 00606959033184 FDA UDI
510(k) Number: K043006 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Stationary oxygen concentrator

Mill, 10 Lpm, Conc Canadian by Respironics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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NewLife Intensity — Airsep Corp. · Class II
DeVilbiss — DeVilbiss Healthcare LLC. · Class II
Oxygen Concentrator — Proactive Medical Products · Class II

Cleared under the same submission

K043006 also covers:

Millennium M10 — Respironics, Inc.
Millennium M10 — Respironics, Inc.

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: Respironics, Inc.

Sources (1)

FDA UDI f38a0dae-bb5a-435e-bcce-0a0f401d0b65 37 fields · synced May 30, 2026