Identity
- Trade Name
- DISCOV-R FDA UDI
- Generic Name
- Mobile/portable oxygen concentrator FDA UDI
- Device Name
- DISCOV-R Cart FDA UDI
- Model / Reference
- 72391 FDA UDI
- Description
- DISCOV-R Cart FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850029991144 FDA UDI
- 510(k) Number
- K203086 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
- Not 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
A comprehensive mobile/portable mains electricity (AC-powered) oxygen concentrator device designed to concentrate oxygen from ambient air and deliver the concentrated O2, typically through an attached nasal cannula, for patients requiring oxygen therapy.
Cleared under the same submission
K203086 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
- Belluscura Plc
Sources (1)
- FDA UDI 13b2923c-c738-4fbc-ba45-7a2c606ecaa9 36 fields · synced Jul 20, 2026