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: Cardiopulmonary resuscitation kit, reusable FDA UDI
Device Name: Resuscitator with Reservoir Bag FDA UDI
Model / Reference: 299006000 FDA UDI
Description: Resuscitator with Reservoir Bag FDA UDI

Identifiers

Catalog Number: 299006000 FDA UDI
Primary DI / UDI-DI: 05707480035243 FDA UDI
FDA Product Code: OEV FDA UDI
GMDN Term: Cardiopulmonary resuscitation kit, 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Cardiopulmonary resuscitation kit, 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 41c77e35-5a62-40a9-8845-fc09c9fe7f78 37 fields · synced May 31, 2026