Catalog Number

-

Brand Name

Portex

Version/Model Number

VP1338

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

K002506,K002506

Product Code

CAH

Product Code Name

Filter, bacterial, breathing-circuit

Public Device Record Key

cb543b9d-5c87-4926-a4c8-c488de1f1f73

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

April 06, 2017

Package DI Number

35019517094897

Quantity per Package

1

Contains DI Package

15019517094893

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

EACH