Catalog Number

36-SPC1000-STK

Brand Name

Vyaire

Version/Model Number

2.5

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

K141936

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Public Device Record Key

93d3a1eb-dc6d-4c4d-97a5-7d7f8f7561aa

Public Version Date

March 16, 2021

Public Version Number

2

DI Record Publish Date

March 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-