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Nasal Alar SpO2 Sensor FAST Only, 20/CS

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 989803205381

by Philips Medical Systems

Identity

Trade Name
Nasal Alar SpO2 Sensor FAST Only, 20/CS EUDAMED
Nasal Alar SpO2 Sensor FDA UDI
Generic Name
Pulse oximeter probe, single-use FDA UDI
Device Name
Alar Nasal SpO2 Sensors EUDAMED
Nasal Alar SpO2 Sensor FAST Only, 20/CS. Case of Philips Nasal Alar Single Patient Use SpO2 Sensor, FAST only version, 20 sensors per case FDA UDI
Model / Reference
989803205381 EUDAMED
Nasal Alar SpO2 Sensor FAST Only, 20/CS FDA UDI
Description
Nasal Alar SpO2 Sensor FAST Only, 20/CS. Case of Philips Nasal Alar Single Patient Use SpO2 Sensor, FAST only version, 20 sensors per case FDA UDI

Identifiers

Catalog Number
989803205381 FDA UDI
Primary DI / UDI-DI
20884838097173 EUDAMEDFDA UDI
Basic UDI-DI
B-20884838097173 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 EUDAMED
Class 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 FAST Only, 20/CS by Philips Medical Systems — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

EUDAMED SRN
US-MF-000002321
Authorised Representative
Philips Medical Systems Nederland B.V. NL-AR-000001422

Sources (2)

  • EUDAMED 0cbd2c86-f20f-4dd6-b88a-67d13fa9a4c9 61 fields · synced Jun 19, 2026
  • FDA UDI 20fd5544-c705-4e89-80c5-c29b8f3198aa 36 fields · synced May 30, 2026