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SpO2 Grip Starter Kit (20 piece)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 989803167111
Identity
- Trade Name
- SpO2 Grip Starter Kit (20 piece) EUDAMEDMR Patient Care SpO2 Grip Starter Kit (20 piece) FDA UDI
- Generic Name
- Pulse oximeter probe, single-use FDA UDI
- Device Name
- Reusable SpO2 Clips and Single use Grips EUDAMEDStarter pack for the Quick Connect SpO2 Sensor (989803161991) that includes 5 each of Adult, Pediatric, Infant and Neonatal disposable grips. FDA UDI
- Model / Reference
- 989803167111 EUDAMEDSpO2 Grip Starter Kit (20 piece) FDA UDI
- Description
- Starter pack for the Quick Connect SpO2 Sensor (989803161991) that includes 5 each of Adult, Pediatric, Infant and Neonatal disposable grips. FDA UDI
Identifiers
- Catalog Number
- 989803167111 FDA UDI
- Primary DI / UDI-DI
- 00884838128408 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM1070LW EUDAMED
- FDA Product Code
- MWI 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
- 870.2300 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- 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
SpO2 Grip Starter Kit (20 piece) by Philips Medizin Systeme Böblingen GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 0884838BM1070LW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- EUDAMED SRN
- DE-MF-000006026
Sources (2)
- EUDAMED 8dc5ed3c-7e9b-46b2-a36e-4332c48df913 61 fields · synced Jun 20, 2026
- FDA UDI 9159875c-9223-449b-8890-233eeca438b1 35 fields · synced May 30, 2026