Catalog Number

36-PSA1100

Brand Name

Vyaire

Version/Model Number

36-PSA1100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 10, 2019

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

K113096

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Public Device Record Key

344d4717-62fd-4283-9660-5630683a2c65

Public Version Date

March 08, 2022

Public Version Number

6

DI Record Publish Date

April 17, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-