Medline

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name: Medline FDA UDI
Generic Name: Resuscitator face mask, single-use FDA UDI
Device Name: RESUS BAG, INFANT, BAG RES, 3 MASKS FDA UDI
Model / Reference: CPRM33123 FDA UDI
Description: RESUS BAG, INFANT, BAG RES, 3 MASKS FDA UDI

Identifiers

Catalog Number: CPRM33123 FDA UDI
Primary DI / UDI-DI: 10193489019445 FDA UDI
FDA Product Code: BTM FDA UDI
GMDN Term: Resuscitator face mask, 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Resuscitator face mask, single-use

Medline by Medline Industries, Inc. — 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: Medline Industries, Inc.

Sources (1)

FDA UDI 6a9ad0fb-a1b4-4d73-ab02-910f984314a2 35 fields · synced Jun 6, 2026