The BAG II Resuscitator Adult w/mask #4

FDA UDIEUDAMED

Class II (US FDA UDI)

by Laerdal Medical Corp.

Identity

Trade Name: The BAG II Resuscitator Adult w/mask #4 FDA UDI
Generic Name: Pulmonary resuscitator, manual, single-use FDA UDI
Device Name: The BAG II are manual resuscitators incorporating a bag and valve, intended to provide emergency ventilation or ventilation during patient transport. The infant model is intended for patients weighing between 5 to 12 kgs, the child model is intended for patients weighing between 10 to 30 kgs, and the adult model is intended for patients weighing more than 30 kgs approximate weight FDA UDI
Model / Reference: 845141 FDA UDI
Description: The BAG II are manual resuscitators incorporating a bag and valve, intended to provide emergency ventilation or ventilation during patient transport. The infant model is intended for patients weighing between 5 to 12 kgs, the child model is intended for patients weighing between 10 to 30 kgs, and the adult model is intended for patients weighing more than 30 kgs approximate weight FDA UDI

Identifiers

Catalog Number: 845141 FDA UDI
Primary DI / UDI-DI: 07045432067965 FDA UDI
FDA Product Code: BTM FDA UDI
GMDN Term: Pulmonary resuscitator, manual, single-use 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

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Pulmonary resuscitator, manual, single-use

The BAG II Resuscitator Adult w/mask #4 by Laerdal Medical Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Also classified as Pulmonary resuscitator, manual, single-use.

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Ventlab — Ventlab Corp. · Class I
Ventlab — Ventlab Corp. · Class II
Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Laerdal Medical Corp.

Sources (2)

FDA UDI 7f9f4c30-eb53-4631-9ef1-1d3f23d20749 36 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced Jun 1, 2026