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Oxymizer Pendant Conserving Device
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref P-224
by Inovo, Inc.
Identity
- Trade Name
- Drive FDA UDIOXYMIZER FDA UDI
- Generic Name
- Therapeutic agent nebulizer, benchtop FDA UDIOxygen therapy conserving regulator FDA UDI
- Device Name
- Oxymizer Pendant Conserving Device EUDAMEDOxymizer® Disposable Oxygen Conserver FDA UDI
- Model / Reference
- P-224 EUDAMEDFDA UDI
- Description
- Oxymizer® Disposable Oxygen Conserver FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822383274508 EUDAMEDFDA UDI00814470020112 FDA UDI
- Basic UDI-DI
- 1822383OXYMIZ1A6 EUDAMED
- 510(k) Number
- K834588 FDA UDI
- FDA Product Code
- NFB FDA UDI
- EMDN Code
- R060202 OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS EUDAMED
- GMDN Term
- Therapeutic agent nebulizer, benchtop FDA UDIOxygen therapy conserving 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 UDIFDA 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
Yes
FDA UDIFDA UDI
Lot / Batch Number
No
FDA UDIFDA UDI
Serial Number
Yes
FDA UDIFDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Oxymizer Pendant 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 | 1822383OXYMIZ1A6 | 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 (3)
- EUDAMED c0d78d51-e2a0-4bfb-ada6-00f1e4ac2f91 61 fields · synced Jun 19, 2026
- FDA UDI d5ed3898-a7f7-4818-9840-9e425234d1cd 33 fields · synced May 30, 2026
- FDA UDI c74890a6-b3e5-432d-9159-4cc274760002 34 fields · synced May 30, 2026