Catalog Number

-

Brand Name

Portex

Version/Model Number

225-3523-804

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

K910509,K910509

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Public Device Record Key

808b56de-4607-457a-ac7d-d13c27a034f6

Public Version Date

October 21, 2020

Public Version Number

6

DI Record Publish Date

October 11, 2016

Package DI Number

30351688416753

Quantity per Package

50

Contains DI Package

10351688416759

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON