Ras-45

FDA UDI

Class II (US FDA UDI)

by Masimo Corporation

Identity

Trade Name: RAS-45 FDA UDI
Generic Name: Electronic acoustic stethoscope FDA UDI
Device Name: RAS-45 Inf/Neo RRa Infant/Neonatal Acoustic Respiration Sensor FDA UDI
Model / Reference: 4425 FDA UDI
Description: RAS-45 Inf/Neo RRa Infant/Neonatal Acoustic Respiration Sensor FDA UDI

Identifiers

Primary DI / UDI-DI: 10843997013113 FDA UDI
FDA Product Code: BZQ FDA UDI
GMDN Term: Electronic acoustic stethoscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.2375 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: Electronic acoustic stethoscope

Ras-45 by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 86ae46bb-61b8-49c5-a14d-abc53e9a57f6 34 fields · synced May 30, 2026