Catalog Number

11314044

Brand Name

C-SAA ANALYT MODULE ASSY 2120I

Version/Model Number

11314044

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

K162977

Product Code

GKZ

Product Code Name

Counter, differential cell

Public Device Record Key

e4f5745b-2195-40a6-baa2-ef4697aad1fa

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

March 23, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-