Catalog Number

777404-101

Brand Name

VMAX

Version/Model Number

777404-101

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

K942211

Product Code

BTY

Product Code Name

CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

Public Device Record Key

be841a2d-73f2-4eec-ba63-ef03fff87fe5

Public Version Date

April 12, 2021

Public Version Number

1

DI Record Publish Date

April 02, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-