Catalog Number

943-905

Brand Name

S53516 10mL REF 943-905 Electrode Cleaner

Version/Model Number

943-905

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 16, 2020

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CHL

Product Code Name

Electrode measurement, blood-gases (pco2, po2) and blood ph

Public Device Record Key

4ebb2562-cf53-4eeb-83ba-377639f1a97b

Public Version Date

August 15, 2022

Public Version Number

2

DI Record Publish Date

September 21, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-