Catalog Number

-

Brand Name

Ventlab

Version/Model Number

BF103

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

CAH

Product Code Name

Filter, Bacterial, Breathing-Circuit

Public Device Record Key

046d8ad8-1e83-4c1e-899e-b3df140f8a7d

Public Version Date

September 22, 2020

Public Version Number

3

DI Record Publish Date

October 05, 2016

Package DI Number

20889483104719

Quantity per Package

50

Contains DI Package

10889483104712

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box