Catalog Number

-

Brand Name

LIFE®CPR Mask

Version/Model Number

LIFE-100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K010191

Product Code

CBP

Product Code Name

Valve, Non-Rebreathing

Public Device Record Key

c09b7ce2-05d7-4e1e-afcb-40f8a5229488

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-