Reusable Sensor - Y

FDA UDI

Class II (US FDA UDI)

by Mediaid Inc

Identity

Trade Name: Reusable Sensor - Y FDA UDI
Generic Name: Pulse oximeter, line-powered FDA UDI
Device Name: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the Oximeter. The sensor contains three optical components, (LED) that serves as light sources and one photodiode that acts as light detector. The optical components are housed in adhesive film/rigid spring-loaded clip, or foam and Velcro wrap. The sensor cable is terminated by a connector as specified by the different make/ manufacturer of the pulse Oximeter, with an optional adapter cable for compatible models. FDA UDI
Model / Reference: CST070-31049 FDA UDI
Description: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the Oximeter. The sensor contains three optical components, (LED) that serves as light sources and one photodiode that acts as light detector. The optical components are housed in adhesive film/rigid spring-loaded clip, or foam and Velcro wrap. The sensor cable is terminated by a connector as specified by the different make/ manufacturer of the pulse Oximeter, with an optional adapter cable for compatible models. FDA UDI

Identifiers

Primary DI / UDI-DI: B425CST070310492 FDA UDI
510(k) Number: K041964 FDA UDI
FDA Product Code: DQA FDA UDI
GMDN Term: Pulse oximeter, line-powered 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Pulse oximeter, line-powered

Reusable Sensor - Y by Mediaid Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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B100 SERIES — BETA BIOMED SERVICES INC · Class II
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Radical Docking Station RDS-3 signal extraction pulse oximeter — MASIMO CORPORATION · Class II

Cleared under the same submission

K041964 also covers:

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: Mediaid Inc

Sources (1)

FDA UDI 47b12b2a-6b99-49f1-8254-49565883f946 35 fields · synced Jun 1, 2026