Identity
- Trade Name
- Neonatal SpO2 Grips (20) EUDAMEDMR Patient Care Neonatal SpO2 Grips (20) FDA UDI
- Generic Name
- Pulse oximeter probe, single-use FDA UDI
- Device Name
- Reusable SpO2 Clips and Single use Grips EUDAMEDBox of 20 Disposable SpO2 finger grips designed for use with the Quick Connect SPO2 Sensor (989803161991) - Sized for Neonatal patients FDA UDI
- Model / Reference
- 989803166581 EUDAMEDNeonatal SpO2 Grips (20) FDA UDI
- Description
- Box of 20 Disposable SpO2 finger grips designed for use with the Quick Connect SPO2 Sensor (989803161991) - Sized for Neonatal patients FDA UDI
Identifiers
- Catalog Number
- 989803166581 FDA UDI
- Primary DI / UDI-DI
- 10884838101019 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM453T3 EUDAMED
- Unit of Use DI
- 00884838101012 EUDAMED
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
- GMDN Term
- Pulse oximeter probe, single-use 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Neonatal SpO2 Grips (20) 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 50222c1d-ad56-4801-a00c-a8d382cee021 61 fields · synced Oct 6, 2026
- FDA UDI 996e95bc-26dc-48c2-93da-f3daf0b58b90 37 fields · synced May 30, 2026