Catalog Number

-

Brand Name

AggRAM Module (Domestic)

Version/Model Number

8JF52001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K050053

Product Code

JPA

Product Code Name

SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Public Device Record Key

c5c9a7db-e5ff-4716-af73-f432ccf7b682

Public Version Date

September 16, 2022

Public Version Number

4

DI Record Publish Date

September 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-