Catalog Number

OPOE05

Brand Name

INNOVANCE Heparin LMW Control 1

Version/Model Number

10873534

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K162540,K162540

Product Code

GGN

Product Code Name

Plasma, coagulation control

Public Device Record Key

771fd75a-e2f8-4a1e-869e-076822bc303a

Public Version Date

November 18, 2021

Public Version Number

5

DI Record Publish Date

September 15, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-