Catalog Number

-

Brand Name

Portex

Version/Model Number

C37091804D-NL

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

bb121ca3-45d0-41d1-8d28-032dd3d1829d

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

May 18, 2017

Package DI Number

35019517093739

Quantity per Package

20

Contains DI Package

15019517093735

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX