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Bonsai Oxygen Conserving Device
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref OM-812CEModel OM-812CE
by Inovo, Inc.
Identity
- Trade Name
- BONSAI FDA UDI
- Generic Name
- Non-fixed medical gas cylinder regulator FDA UDI
- Device Name
- Bonsai Oxygen Conserving Device EUDAMEDBonsai Velocity Conserver CE Mark FDA UDI
- Model / Reference
- OM-812CE EUDAMEDFDA UDI
- Description
- Bonsai Velocity Conserver CE Mark FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814470020327 EUDAMEDFDA UDI
- Basic UDI-DI
- 1822383BONSAI1S7 EUDAMED
- 510(k) Number
- K070740 FDA UDI
- FDA Product Code
- NFB FDA UDI
- EMDN Code
- R060202 OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS EUDAMED
- GMDN Term
- Non-fixed medical gas cylinder regulator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5905 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 Oxygen Conserving Device by Inovo, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 1822383BONSAI1S7 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Inovo, Inc.
- EUDAMED SRN
- US-MF-000023457
- Authorised Representative
- Drive Medical GmbH & Co. KG DE-AR-000044475
Sources (2)
- EUDAMED 71be81ad-d73c-494f-afa8-b2fe394022cf 61 fields · synced Jun 18, 2026
- FDA UDI c7623fe5-2e28-45d3-b45f-159cc4dd85e3 34 fields · synced May 29, 2026