Catalog Number

-

Brand Name

Ventlab

Version/Model Number

br130

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

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

88d40da0-0c03-467b-9ff8-90a8ac323e34

Public Version Date

June 08, 2021

Public Version Number

3

DI Record Publish Date

September 29, 2016

Package DI Number

20889483104238

Quantity per Package

20

Contains DI Package

10889483104231

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box