Catalog Number

-

Brand Name

Dispo-Med

Version/Model Number

DM-7100/CO-10FTMT

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 24, 2021

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

Product Code

CCK

Product Code Name

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Public Device Record Key

b37dc34d-5c6a-425c-968a-194a89edf25c

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

December 24, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-