Catalog Number

-

Brand Name

N/A

Version/Model Number

30-01-023

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,K112783

Product Code

BTL

Product Code Name

Ventilator, Emergency, Powered (Resuscitator)

Public Device Record Key

538ab416-e637-41f9-80d1-96c33f5896f7

Public Version Date

April 15, 2021

Public Version Number

4

DI Record Publish Date

May 13, 2016

Package DI Number

14250105615453

Quantity per Package

1

Contains DI Package

04250105615456

Package Discontinue Date

April 14, 2021

Package Status

Not in Commercial Distribution

Package Type

-