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Nasal Alar SpO2 Sensor MLT CPTL, 24/CS
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 989803205391
Identity
- Trade Name
- Nasal Alar SpO2 Sensor MLT CPTL, 24/CS EUDAMEDNasal Alar SpO2 Sensor FDA UDI
- Generic Name
- Pulse oximeter probe, single-use FDA UDI
- Device Name
- Alar Nasal SpO2 Sensors EUDAMEDNasal Alar SpO2 Sensor MLT CPTL, 24/CS. 1 case of Philips Nasal Alar single patient use, multi-compatible SpO2 sensors, 24 sensors per case FDA UDI
- Model / Reference
- 989803205391 EUDAMEDNasal Alar SpO2 Sensor MLT CPTL, 24/CS FDA UDI
- Description
- Nasal Alar SpO2 Sensor MLT CPTL, 24/CS. 1 case of Philips Nasal Alar single patient use, multi-compatible SpO2 sensors, 24 sensors per case FDA UDI
Identifiers
- Catalog Number
- 989803205391 FDA UDI
- Primary DI / UDI-DI
- 20884838097548 EUDAMEDFDA UDI
- Basic UDI-DI
- B-20884838097548 EUDAMED
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
- GMDN Term
- Pulse oximeter probe, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 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
No
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
Nasal Alar SpO2 Sensor MLT CPTL, 24/CS by Philips Medical Systems — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253887 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-20884838097548 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems
- EUDAMED SRN
- US-MF-000002321
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (3)
- EUDAMED 9ef13ef3-a901-45b7-85cd-6d388c20de67 61 fields · synced Jul 21, 2026
- FDA UDI f95c5a3d-e100-4331-bede-73db7c9e504d 36 fields · synced May 29, 2026
- FDA 510(k) K253887 1 fields · synced May 18, 2026