Catalog Number

-

Brand Name

CPR Bag

Version/Model Number

10-58000

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K911622,K911622

Product Code

BTM

Product Code Name

Ventilator, Emergency, Manual (Resuscitator)

Public Device Record Key

62848d65-a254-4dff-91f5-ff31ee858634

Public Version Date

May 28, 2020

Public Version Number

4

DI Record Publish Date

October 22, 2015

Package DI Number

30641043580008

Quantity per Package

6

Contains DI Package

10641043580004

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-