Rad-97

FDA UDI

Class II (US FDA UDI)

by Masimo Corporation

Identity

Trade Name: Rad-97 FDA UDI
Generic Name: Pulse Co-oximeter FDA UDI
Device Name: Rad-97 with non-invasive blood pressure FDA UDI
Model / Reference: 9867 FDA UDI
Description: Rad-97 with non-invasive blood pressure FDA UDI

Identifiers

Primary DI / UDI-DI: 00843997013857 FDA UDI
510(k) Number: K180046 FDA UDI
FDA Product Code: DQA FDA UDI
GMDN Term: Pulse Co-oximeter 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

Yes

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 Co-oximeter

Rad-97 by Masimo Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Pulse Co-oximeter.

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Radius-PPG — MASIMO CORPORATION · Class II
Rad-97 — MASIMO CORPORATION · Class II
Pronto™ Pulse CO-Oximeter® — MASIMO CORPORATION · Class II

Cleared under the same submission

K180046 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: Masimo Corporation

Sources (1)

FDA UDI 4fb5bb91-c285-4e25-a52e-f3b7c4113959 36 fields · synced May 30, 2026