Catalog Number

SIB100

Brand Name

Astra Spirometer

Version/Model Number

100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 2020

Issuing Agency

In HIBCC

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

K061571

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Public Device Record Key

a3dca7bb-d870-4624-a563-55f3ae2996e8

Public Version Date

March 08, 2022

Public Version Number

6

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-