Mark IV Baby Resuscitator

FDA UDI

Class II (US FDA UDI)

by Ambu A/S

Identity

Trade Name: Mark IV Baby Resuscitator FDA UDI
Generic Name: Pulmonary resuscitator, manual, reusable FDA UDI
Device Name: Ambu Mark IV Baby with open oxygen reservoir and Rendall Baker face mask size 0 FDA UDI
Model / Reference: 299002000 FDA UDI
Description: Ambu Mark IV Baby with open oxygen reservoir and Rendall Baker face mask size 0 FDA UDI

Identifiers

Catalog Number: 299002000 FDA UDI
Primary DI / UDI-DI: 05707480035205 FDA UDI
FDA Product Code: BTM FDA UDI
GMDN Term: Pulmonary resuscitator, manual, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5915 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Pulmonary resuscitator, manual, reusable

Mark IV Baby Resuscitator by Ambu A/S — 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: Ambu A/S

Sources (1)

FDA UDI 84899532-0162-47fa-bc70-8af4e449cf06 36 fields · synced Jun 1, 2026