Catalog Number

-

Brand Name

Dispo-Med CO2 Sampling Line w/Filter

Version/Model Number

DM-7100/CO-ST

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

K143127,K143127

Product Code

CCK

Product Code Name

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Public Device Record Key

8754c619-7120-452f-8306-90a54cb6e0b0

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

December 17, 2018

Package DI Number

09555866300791

Quantity per Package

25

Contains DI Package

09555866300784

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-