Catalog Number

-

Brand Name

Portex

Version/Model Number

27-7001

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

BWF

Product Code Name

SPIROMETER, THERAPEUTIC (INCENTIVE)

Public Device Record Key

9cebbc17-9836-4b7c-9e7f-a67dca5c5fa6

Public Version Date

June 22, 2021

Public Version Number

2

DI Record Publish Date

April 06, 2021

Package DI Number

50788942270013

Quantity per Package

10

Contains DI Package

10788942270015

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case