Catalog Number

OPOB05

Brand Name

INNOVANCE Heparin Calibrator

Version/Model Number

10873530

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

Product Code

JIS

Product Code Name

Calibrator, primary

Public Device Record Key

dbef1399-18a9-494f-98ad-35271918c802

Public Version Date

November 18, 2021

Public Version Number

5

DI Record Publish Date

September 11, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-