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MySign® O incl. OOM111

by Honeywell Healthcare Solutions GmbH

MySign® O incl. OOM111 (1001825) is a Class II device made by Honeywell Healthcare Solutions GmbH, listed in FDA GUDID since 22 Sep 2016 (UDI-DI 04036616009324), 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 Number04036616009324 UDI-DI Date22 Sep 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  • Withdrawn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
MySign® O
Generic name
Respiratory oxygen monitor, line-powered
Model / Ref / Catalog
incl. OOM111, 1001825
Primary DI / UDI-DI
04036616009324
FDA product code
CCL
GMDN term
Respiratory oxygen monitor, line-powered
Device class
Class II
Regulation number
868.1720
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Size
Height — 42 Millimeter
Length — 166 Millimeter
Width — 242 Millimeter

Related devices

Category: Respiratory oxygen monitor, line-powered

Similar devices

Other devices filed under FDA product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase).

Other devices from Honeywell Healthcare Solutions GmbH

See all devices from Honeywell Healthcare Solutions GmbH →

Properties

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