Catalog Number

00022550030

Brand Name

HemosIL D-Dimer HS 500 Controls (Liquid)

Version/Model Number

0022550030

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

K133582

Product Code

GGN

Product Code Name

Plasma, coagulation control

Public Device Record Key

3e9b6fac-91bd-4e2c-9018-20d218eacde5

Public Version Date

July 13, 2021

Public Version Number

4

DI Record Publish Date

March 07, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-