MySign® S

FDA UDI

Class II (US FDA UDI)

by Honeywell Healthcare Solutions GmbH

Identity

Trade Name: MySign® S FDA UDI
Generic Name: Pulse oximeter FDA UDI
Device Name: MySign® S wo/power supply FDA FDA UDI
Model / Reference: wo/power supply FDA FDA UDI
Description: MySign® S wo/power supply FDA FDA UDI

Identifiers

Catalog Number: 1002197 FDA UDI
Primary DI / UDI-DI: 04036616009874 FDA UDI
510(k) Number: K133064 FDA UDI
FDA Product Code: DQA FDA UDI
GMDN Term: Pulse 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

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: Pulse oximeter

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Honeywell Healthcare Solutions GmbH

Sources (1)

FDA UDI 3ebde7bf-7d8d-4137-887d-f215c63d9b52 37 fields · synced Jun 1, 2026