Catalog Number

500326-100

Brand Name

NA

Version/Model Number

500326-100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2017

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123896,K123896

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Public Device Record Key

de292d69-a016-43d3-9584-a5f0add99190

Public Version Date

March 23, 2020

Public Version Number

4

DI Record Publish Date

October 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-