Catalog Number

10720780

Brand Name

ADVIA Chemistry CO2_c

Version/Model Number

10720780

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K100289,K100289

Product Code

KHS

Product Code Name

ENZYMATIC, CARBON-DIOXIDE

Public Device Record Key

e1915703-8cb1-46aa-820e-eb4ad71254b6

Public Version Date

November 18, 2021

Public Version Number

6

DI Record Publish Date

May 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-