Catalog Number

-

Brand Name

PORTEX

Version/Model Number

27-8050

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

f96a470f-0f10-4975-9ebe-ea999e767ba6

Public Version Date

June 22, 2021

Public Version Number

2

DI Record Publish Date

April 07, 2021

Package DI Number

35019517128295

Quantity per Package

50

Contains DI Package

15019517128291

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case