Catalog Number

-

Brand Name

Ventlab

Version/Model Number

AF1040MBN-P

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

-

Product Code

BTM

Product Code Name

Ventilator, Emergency, Manual (Resuscitator)

Public Device Record Key

b4dc2b85-dc31-45a6-93fb-706a1fe6700e

Public Version Date

October 21, 2019

Public Version Number

4

DI Record Publish Date

November 09, 2016

Package DI Number

20889483112936

Quantity per Package

10

Contains DI Package

10889483112939

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box