Catalog Number

1059-E

Brand Name

Hospitak, Mouth to Mask Resuscitator with Filter Adult Large Mask

Version/Model Number

1059-E

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 08, 2021

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

K873286,K873286

Product Code

BTM

Product Code Name

Ventilator, Emergency, Manual (Resuscitator)

Public Device Record Key

af7b6de4-eb8c-49cb-b194-64741416d100

Public Version Date

April 09, 2021

Public Version Number

3

DI Record Publish Date

October 15, 2015

Package DI Number

20844249003347

Quantity per Package

20

Contains DI Package

00084424900334

Package Discontinue Date

April 08, 2021

Package Status

Not in Commercial Distribution

Package Type

case