Catalog Number

-

Brand Name

SINGLE USE ADULT RESUSCITATOR BALL 1600ML W/POP-OFF , 60cm H2O & MANOMETER PORT

Version/Model Number

RE-24437

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K021442,K021442,K021442

Product Code

BTM

Product Code Name

Ventilator, Emergency, Manual (Resuscitator)

Public Device Record Key

13b752c8-7b8f-4858-ba66-6086e4e83a5c

Public Version Date

February 04, 2020

Public Version Number

4

DI Record Publish Date

May 23, 2016

Package DI Number

14716770244379

Quantity per Package

24

Contains DI Package

04716770244372

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton