Identity
- Trade Name
- NewLife Intensity FDA UDI
- Generic Name
- Stationary oxygen concentrator FDA UDI
- Device Name
- Oxygen Concentrator, 1-8 LPM, Single Flow Meter, with Oxygen Monitor Option FDA UDI
- Model / Reference
- AS094-101 FDA UDI
- Description
- Oxygen Concentrator, 1-8 LPM, Single Flow Meter, with Oxygen Monitor Option FDA UDI
Identifiers
- Primary DI / UDI-DI
- M638AS0941010 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Stationary oxygen concentrator
NewLife Intensity by Airsep Corp. — 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
- 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
- DeVilbiss — DeVilbiss Healthcare LLC. · Class II
- Oxygen Concentrator — Proactive Medical Products · Class II
- Inogen At Home Stationary Concentrator — Inogen, Inc. · Class II
- Millennium M10 — Respironics, Inc. · Class II
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
- Airsep Corp.
Sources (1)
- FDA UDI a12e9e18-169e-42c8-9d84-441338840d1e 33 fields · synced May 30, 2026