Catalog Number

BP7559

Brand Name

OPTI CCA E-Cl Cassette

Version/Model Number

1

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

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

K131126

Product Code

CGZ

Product Code Name

Electrode, Ion-Specific, Chloride

Public Device Record Key

4e4edb48-c294-49b5-b74f-cdfca1470c49

Public Version Date

September 11, 2019

Public Version Number

1

DI Record Publish Date

September 03, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-