Identity
- Trade Name
- Focus FDA UDI
- Generic Name
- Mobile/portable oxygen concentrator FDA UDI
- Device Name
- Portable Oxygen Concentrator, 2 LPM equivalent FDA UDI
- Model / Reference
- AS078-1 FDA UDI
- Description
- Portable Oxygen Concentrator, 2 LPM equivalent FDA UDI
Identifiers
- Primary DI / UDI-DI
- M638AS07810 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
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: Mobile/portable oxygen concentrator
Focus by Airsep Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mobile/portable oxygen concentrator.
- Invacare F-Tube, PVC for PerectO2 and PerfectO2V — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- SimplyGo Mini — Respironics, Inc. · Class II
- SimplyGo Mini — Respironics, Inc. · Class II
- SimplyGo Mini — Respironics, Inc. · Class II
- FreeStyle — CAIRE INC. · Class II
- Invacare Panel Control for PerfectO2 and PerfectO2V — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- DISCOV-R — BELLUSCURA PLC · Class II
- GCE — GAS CONTROL EQUIPMENT LIMITED · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Airsep Corp.
Sources (1)
- FDA UDI 39f8559e-d8c2-439b-8c4f-ec67e7a28d20 33 fields · synced Jun 1, 2026