Catalog Number

-

Brand Name

Hemostasis System

Version/Model Number

07-615-US

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

K140893,K140893

Product Code

JOZ

Product Code Name

SYSTEM, AUTOMATED PLATELET AGGREGATION

Public Device Record Key

d9e0ebdf-fc37-405d-8bc5-2abb7b373b99

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 11, 2017

Package DI Number

20812747018378

Quantity per Package

10

Contains DI Package

10812747018371

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-