Catalog Number

-

Brand Name

Portex

Version/Model Number

21-1530

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

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

BWF

Product Code Name

SPIROMETER, THERAPEUTIC (INCENTIVE)

Public Device Record Key

f1606084-c3b5-4763-8793-dcc9e07f4fd3

Public Version Date

June 22, 2021

Public Version Number

3

DI Record Publish Date

October 11, 2016

Package DI Number

50788942215304

Quantity per Package

10

Contains DI Package

10788942215306

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE