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MySign® O

FDA UDI

Class II (US FDA UDI)

by Honeywell Healthcare Solutions GmbH

Identity

Trade Name
MySign® O FDA UDI
Generic Name
Respiratory oxygen monitor, line-powered FDA UDI
Device Name
MySign® O incl. OOM111 FDA UDI
Model / Reference
incl. OOM111 FDA UDI
Description
MySign® O incl. OOM111 FDA UDI

Identifiers

Catalog Number
1001825 FDA UDI
Primary DI / UDI-DI
04036616009324 FDA UDI
FDA Product Code
CCL FDA UDI
GMDN Term
Respiratory oxygen monitor, line-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1720 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
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Height — 42 Millimeter FDA UDI
Length — 166 Millimeter FDA UDI
Width — 242 Millimeter FDA UDI

Category: Respiratory oxygen monitor, line-powered

MySign® O by Honeywell Healthcare Solutions GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Respiratory oxygen monitor, line-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Honeywell Healthcare Solutions GmbH

Sources (1)

  • FDA UDI 291c4997-d2c5-45b5-bdeb-5b670c077e58 36 fields · synced Jun 6, 2026