Catalog Number

Z02NI744EDC000

Brand Name

Vyaire

Version/Model Number

Pulmonary Function Cal Gas

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

-

Product Code

BXK

Product Code Name

Gas, Calibration (Specified Concentration)

Public Device Record Key

3f37af55-5094-48b8-a4c2-76f89c331257

Public Version Date

March 09, 2020

Public Version Number

1

DI Record Publish Date

March 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-