Medifirst CPR Mask

FDA UDI

Class II (US FDA UDI)

by Medique Products

Identity

Trade Name: Medifirst CPR Mask FDA UDI
Generic Name: Cardiopulmonary resuscitation mask, single-use FDA UDI
Model / Reference: 80201 FDA UDI

Identifiers

Catalog Number: 80201 FDA UDI
Primary DI / UDI-DI: 00347682802011 FDA UDI
510(k) Number: K112126 FDA UDI
FDA Product Code: CBP FDA UDI
GMDN Term: Cardiopulmonary resuscitation mask, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5870 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

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: Cardiopulmonary resuscitation mask, single-use

Medifirst CPR Mask by Medique Products — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K112126 also covers:

Medi-First CPR Kit — Medique Products

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: Medique Products

Sources (1)

FDA UDI 42e8b6aa-90f6-4594-9694-cda0f81a883e 35 fields · synced Jun 1, 2026