Identity
- Trade Name
- Resp-O2 10L Oxygen Concentrator FDA UDI
- Generic Name
- Mobile/portable oxygen concentrator FDA UDI
- Model / Reference
- 33951 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840117342736 FDA UDI
- 510(k) Number
- K222920 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mobile/portable oxygen concentrator
Resp-O2 10L Oxygen Concentrator by Dynarex Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Mobile/portable oxygen concentrator.
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- 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
Cleared under the same submission
K222920 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
- Dynarex Corp.
Sources (1)
- FDA UDI 1da87489-6cc4-478d-a683-74657adb6b96 33 fields · synced May 30, 2026