Catalog Number

-

Brand Name

TEG5000

Version/Model Number

07-045

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

-

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

K993678

Product Code

JPA

Product Code Name

SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Public Device Record Key

0f8be022-50fe-475e-8d22-133ca143a302

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-