Catalog Number

-

Brand Name

Portex

Version/Model Number

8530C-25

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

K991086,K991086,K991086

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Public Device Record Key

2d59e4ba-a657-4ad5-90a5-0c40df41f7bd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 05, 2016

Package DI Number

35019315002865

Quantity per Package

25

Contains DI Package

15019315001710

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX