Duns Number:388240673
Device Description: For use as a high level assayed control for the quantitative measurement of unfractionated For use as a high level assayed control for the quantitative measurement of unfractionated heparin with Berichrom Heparin
Catalog Number
OPBZ03
Brand Name
Berichrom® Heparin UF Control 2
Version/Model Number
10445986
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2021
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
K083175,K083175
Product Code
GGC
Product Code Name
CONTROL, PLASMA, ABNORMAL
Public Device Record Key
0ea2d7f6-b57b-4831-9f02-c491a2985ed5
Public Version Date
September 05, 2022
Public Version Number
6
DI Record Publish Date
September 24, 2016
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 |