Catalog Number

-

Brand Name

VentiSure2

Version/Model Number

301-5800

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

-

Product Code

BTM

Product Code Name

Ventilator, Emergency, Manual (Resuscitator)

Public Device Record Key

20317c59-8411-4870-b592-0a4823c60df9

Public Version Date

November 11, 2019

Public Version Number

4

DI Record Publish Date

September 30, 2016

Package DI Number

10841470105324

Quantity per Package

8

Contains DI Package

00841470105327

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-