Catalog Number

4MSF8-6

Brand Name

N/A

Version/Model Number

4MSF8-6

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

-

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

K151421,K151421

Product Code

CCK

Product Code Name

ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Public Device Record Key

c71a32ad-b0a9-4bce-8511-685fcb3512df

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

November 22, 2018

Package DI Number

10607411961110

Quantity per Package

25

Contains DI Package

00607411961113

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-