Catalog Number

-

Brand Name

Adenosine Diphosphate (ADP)

Version/Model Number

50704

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 11, 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

K910286,K910286

Product Code

GHR

Product Code Name

Reagent, Platelet Aggregation

Public Device Record Key

475ad550-5158-41c4-9b96-22fe11fc583d

Public Version Date

July 13, 2020

Public Version Number

5

DI Record Publish Date

September 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-