Identity
- Trade Name
- Adult SpO2 Clip EUDAMEDMR Patient Care Adult SpO2 Clip FDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Device Name
- Reusable SpO2 Clips and Single use Grips EUDAMEDReusable SpO2 finger clip designed for use with the Quick Connect SPO2 Sensor (989803161991) - Sized for Adult patients FDA UDI
- Model / Reference
- 989803166531 EUDAMEDAdult SpO2 Clip FDA UDI
- Description
- Reusable SpO2 finger clip designed for use with the Quick Connect SPO2 Sensor (989803161991) - Sized for Adult patients FDA UDI
Identifiers
- Catalog Number
- 989803166531 FDA UDI
- Primary DI / UDI-DI
- 10884838100968 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM453T3 EUDAMED
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
- GMDN Term
- Pulse oximeter probe, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- Not 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Adult SpO2 Clip by Invivo, a division of Philips Medical Systems — Class I — 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 | 0884838BM453T3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Invivo, a division of Philips Medical Systems
- EUDAMED SRN
- US-MF-000002177
- Authorised Representative
- Philips Medizin Systeme Böblingen GmbH DE-AR-000006030
Sources (2)
- EUDAMED 238d6134-7e79-4081-90fe-0ecf9ff34a1d 61 fields · synced Oct 6, 2026
- FDA UDI 685a1587-2349-4333-873d-d177aceb45c0 37 fields · synced May 30, 2026