Catalog Number

2-100-1205

Brand Name

Disposable Spirometer Mouthpieces

Version/Model Number

2-100-1205

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

Yes

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

BZG

Product Code Name

Spirometer, Diagnostic

Public Device Record Key

d5d020a3-b15e-40ab-be79-43697a51513d

Public Version Date

March 23, 2020

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

20841709100356

Quantity per Package

4

Contains DI Package

10841709100359

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case