Identity
- Trade Name
- BONSAI FDA UDI
- Generic Name
- Non-fixed medical gas cylinder regulator FDA UDI
- Device Name
- Bonsai Pneumatic Oxygen Conserver CE Mark FDA UDI
- Model / Reference
- OM-810CE FDA UDI
- Description
- Bonsai Pneumatic Oxygen Conserver CE Mark FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814470020297 FDA UDI
- 510(k) Number
- K070740 FDA UDI
- FDA Product Code
- NFB FDA UDI
- GMDN Term
- Non-fixed medical gas cylinder regulator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5905 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
Yes
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
No
FDA UDI
Bonsai by Inovo, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K070740 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
- Inovo, Inc.
Sources (1)
- FDA UDI fe0947d1-02e2-4be9-b913-2c173ef139c2 35 fields · synced Jun 6, 2026