Catalog Number

36-MS10-STK

Brand Name

Vyaire

Version/Model Number

36-MS10-STK

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

K113096

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Public Device Record Key

8d7573e2-ecb1-4acf-bb84-f550609aeb1b

Public Version Date

March 08, 2022

Public Version Number

4

DI Record Publish Date

March 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-