Identity
- Trade Name
- NewLife Intensity 10 FDA UDI
- Generic Name
- Stationary oxygen concentrator FDA UDI
- Device Name
- NEWLIFE INTENSITY 10 OXYGEN CONCENTRATOR, 10LPM, SINGLE, REFURBISHED FDA UDI
- Model / Reference
- AS099-100U FDA UDI
- Description
- NEWLIFE INTENSITY 10 OXYGEN CONCENTRATOR, 10LPM, SINGLE, REFURBISHED FDA UDI
Identifiers
- Primary DI / UDI-DI
- M766AS099100U0 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 10 by Caire Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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
- konsung — Jiangsu Konsung Bio Medical Science and Technology Co., Ltd. · Class II
- NewLife Intensity — Airsep Corp. · Class II
- DeVilbiss — DeVilbiss Healthcare LLC. · Class II
- Oxygen Concentrator — Proactive Medical Products · Class II
- Inogen At Home Stationary Concentrator — Inogen, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Caire Inc.
Sources (2)
- FDA UDI 870154e7-2bf6-4ba0-9ab7-6d541b6993e2 33 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 1, 2026