Catalog Number

-

Brand Name

Portex

Version/Model Number

C45101817D-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

K910509,K910509

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Public Device Record Key

bd3592be-c24e-4df0-a0b4-9b0ef6b9e9b7

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

September 18, 2020

Package DI Number

35019517236679

Quantity per Package

20

Contains DI Package

15019517236675

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case