Catalog Number

80201

Brand Name

Medifirst CPR Mask

Version/Model Number

80201

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K112126,K112126,K112126

Product Code

CBP

Product Code Name

Valve, Non-Rebreathing

Public Device Record Key

42e8b6aa-90f6-4594-9694-cda0f81a883e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 29, 2017

Package DI Number

30347682802012

Quantity per Package

100

Contains DI Package

00347682802011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box