Catalog Number

12020

Brand Name

Aggreguide

Version/Model Number

A-100

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

JOZ

Product Code Name

System, Automated Platelet Aggregation

Public Device Record Key

ab4294f5-482d-40e9-a961-bc01bbed8b39

Public Version Date

October 01, 2019

Public Version Number

1

DI Record Publish Date

September 23, 2019

Package DI Number

00856893004072

Quantity per Package

20

Contains DI Package

00856893004027

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case