Catalog Number

V-707759

Brand Name

Vyaire

Version/Model Number

V-707759

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K190853

Product Code

BTY

Product Code Name

Calculator, Predicted Values, Pulmonary Function

Public Device Record Key

31fdedd5-dc7f-4e37-a96c-a71b7bf2347f

Public Version Date

March 16, 2021

Public Version Number

2

DI Record Publish Date

January 21, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-