← Back to catalogue
Bonsai Oxygen Conserving Device
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref OM-824
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 Pneumatic Oxygen Conserver FDA UDI
- Model / Reference
- OM-824 EUDAMEDFDA UDI
- Description
- Bonsai Pneumatic Oxygen Conserver FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814470020204 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00814470020204 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 IIb 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00814470020204 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inovo, Inc.
- EUDAMED SRN
- US-MF-000023457
- Authorised Representative
- Drive Medical GmbH & Co. KG DE-AR-000044475
Sources (2)
- EUDAMED dddad3bf-05e1-43c7-8d16-f79d1db8866a 61 fields · synced Jul 11, 2026
- FDA UDI c66f31bb-f7cb-43e4-9935-d130bd4938e6 34 fields · synced May 30, 2026