Catalog Number

-

Brand Name

Ventlab

Version/Model Number

BR204-I

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

ad9209c1-bf57-41b3-8188-5d29bd6fa229

Public Version Date

June 08, 2021

Public Version Number

3

DI Record Publish Date

September 29, 2016

Package DI Number

20889483091019

Quantity per Package

20

Contains DI Package

10889483091012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box