Catalog Number

CAP132

Brand Name

Optimizer

Version/Model Number

CAP132

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

-

Product Code

KDQ

Product Code Name

Bottle, Collection, Vacuum

Public Device Record Key

089ed66f-74ed-453e-9578-0c43f8d0a92b

Public Version Date

January 08, 2021

Public Version Number

6

DI Record Publish Date

September 22, 2016

Package DI Number

4052838015370

Quantity per Package

6

Contains DI Package

04052838015363

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton