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Nonin X-100SP-4

by Nonin Medical, Inc.

Nonin X-100SP-4 is a Class II device made by Nonin Medical, Inc., listed in FDA GUDID since 24 Aug 2016 (UDI-DI 00849686072853), 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 Number00849686072853 UDI-DI Date24 Aug 2016ListedStatusListed 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  • Withdrawn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
Nonin
Generic name
Cerebral oximeter
Model / reference
X-100SP-4
Primary DI / UDI-DI
00849686072853
FDA product code
MUD, DQA
GMDN term
Cerebral oximeter
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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Properties

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