Catalog Number

155601

Brand Name

Ventilair II

Version/Model Number

155601

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"

-

For Single-Use

-

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

K041781

Product Code

BTI

Product Code Name

Compressor, Air, Portable

Public Device Record Key

05eec05d-c9ec-44ac-9346-7d70b14df188

Public Version Date

January 28, 2022

Public Version Number

5

DI Record Publish Date

October 21, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-