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Radius-PPG

FDA UDI

Class II (US FDA UDI)

by Masimo Corporation

Identity

Trade Name
Radius-PPG FDA UDI
Generic Name
Pulse Co-oximeter FDA UDI
Device Name
Radius-PPG Wireless Receiver with M20 Cable FDA UDI
Model / Reference
4588 FDA UDI
Description
Radius-PPG Wireless Receiver with M20 Cable FDA UDI

Identifiers

Primary DI / UDI-DI
00843997014830 FDA UDI
510(k) Number
K183697 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Pulse Co-oximeter

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

Similar devices

Also classified as Pulse Co-oximeter.

Cleared under the same submission

K183697 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Masimo Corporation

Sources (1)

  • FDA UDI a33ee2a5-1564-481a-921a-45779f3ad6cf 36 fields · synced Jun 6, 2026