Catalog Number

-

Brand Name

n/a

Version/Model Number

30-01-003

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 14, 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"

Yes

For Single-Use

-

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

K112783

Product Code

BTL

Product Code Name

Ventilator, Emergency, Powered (Resuscitator)

Public Device Record Key

e1d2d0b4-12ab-4008-bbab-f05018233b58

Public Version Date

April 15, 2021

Public Version Number

3

DI Record Publish Date

April 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-