Catalog Number

-

Brand Name

Ventlab

Version/Model Number

AF1100MX

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

866c62cc-2bfe-4f85-9190-afdaa54aa8e8

Public Version Date

October 21, 2019

Public Version Number

4

DI Record Publish Date

November 12, 2016

Package DI Number

20889483106362

Quantity per Package

10

Contains DI Package

10889483106365

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box