Duns Number:388240673
Device Description: For the quantitative determination of the activity of unfractionated heparin (UFH) and low For the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH)
Catalog Number
OPOA05
Brand Name
INNOVANCE Heparin
Version/Model Number
10873535
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
KFF
Product Code Name
ASSAY, HEPARIN
Public Device Record Key
8de40556-d632-48f7-bbeb-5b4f63e251f2
Public Version Date
November 18, 2021
Public Version Number
6
DI Record Publish Date
September 11, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |