Identity
- Trade Name
- O2 Sensor, O2-Sensor, Medical Oxygen Sensor, oxygen sensor, oxygensensor, FiO2-Sensor EUDAMEDO2-Sensor FDA UDI
- Generic Name
- Respiratory oxygen sensor FDA UDI
- Device Name
- O2 Sensor EUDAMED
- Model / Reference
- M-01 EUDAMEDFDA UDI410001 EUDAMED
Identifiers
- Catalog Number
- 41 00 01 FDA UDI
- Primary DI / UDI-DI
- 04250320600008 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250320600008 EUDAMED
- FDA Product Code
- CCL FDA UDI
- EMDN Code
- Z1203020480 GASEOUS EXCHANGE MONITORING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Respiratory oxygen sensor FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1720 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Respiratory oxygen sensor
O2-Sensor by IT Dr. Gambert GmbH — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Respiratory oxygen sensor.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- IT Dr. Gambert GmbH
Sources (2)
- FDA UDI 83fac358-e949-4eea-82b1-d5851281a6a1 33 fields · synced Jun 19, 2026
- EUDAMED f260dc02-eea1-465d-a4fd-9c6e923e75ac 61 fields · synced Jun 14, 2026