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rainbow SET 4313

by Masimo Corporation

rainbow SET 4313 is a Class II device made by Masimo Corporation, listed in FDA GUDID since 3 Jul 2020 (UDI-DI 10843997012604), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10843997012604 UDI-DI Date3 Jul 2020ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
rainbow SET
Generic name
Patient monitoring system module, pulse oximetry
Model / reference
4313
Primary DI / UDI-DI
10843997012604
FDA product code
DQA
GMDN term
Patient monitoring system module, pulse oximetry
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)