ReSposable™ S-DOS™ 20 SpO2 Pediatric Pulse Oximeter Disposable Optical Sensor

FDA UDI

Class II (US FDA UDI)

by Masimo Corporation

Identity

Trade Name: ReSposable™ S-DOS™ 20 SpO2 Pediatric Pulse Oximeter Disposable Optical Sensor FDA UDI
Generic Name: Pulse oximeter probe, single-use FDA UDI
Model / Reference: 2435 FDA UDI

Identifiers

Primary DI / UDI-DI: 10843997006689 FDA UDI
FDA Product Code: DQA FDA UDI
GMDN Term: Pulse oximeter probe, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Pulse oximeter probe, single-use

ReSposable™ S-DOS™ 20 SpO2 Pediatric Pulse Oximeter Disposable Optical Sensor by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID

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Also classified as Pulse oximeter probe, single-use.

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Masimo Corporation

Sources (1)

FDA UDI 7ad8a19c-a8f6-4b3e-9f3e-357420507d24 33 fields · synced Jun 6, 2026