Catalog Number

45-90133

Brand Name

Turbine Assembly, Bagged for GoSpiro Spirometer

Version/Model Number

45-90133

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

K163249

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Public Device Record Key

c6660362-94c9-4a2d-a9cb-4e99bdbfb234

Public Version Date

March 08, 2022

Public Version Number

3

DI Record Publish Date

March 17, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-