Catalog Number

-

Brand Name

BagEasy® Resuscitator

Version/Model Number

R-562080

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

K940581,K940581

Product Code

BTM

Product Code Name

Ventilator, Emergency, Manual (Resuscitator)

Public Device Record Key

cacbc07d-a1ab-488e-9952-d57f6ea1bfcd

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

December 31, 2021

Package DI Number

10709078013888

Quantity per Package

6

Contains DI Package

00709078013881

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case