Catalog Number

Exhalometer

Brand Name

N/A

Version/Model Number

4521

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"

Yes

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

-

Product Code

BZK

Product Code Name

Spirometer, Monitoring (W/Wo Alarm)

Public Device Record Key

62a7b998-0718-49f0-bd45-e025c35af7bb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 15, 2015

Package DI Number

44710810111295

Quantity per Package

12

Contains DI Package

24710810111291

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton