Duns Number:463625602
Device Description: Grifols Diluent is for use in preparing human red blood cell suspensions used with the DG Grifols Diluent is for use in preparing human red blood cell suspensions used with the DG Gel 8 cards.
Catalog Number
213677
Brand Name
Grifols Diluent
Version/Model Number
213677
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
BK120044,BK120044
Product Code
KSZ
Product Code Name
System, Test, Automated Blood Grouping And Antibody
Public Device Record Key
b23ad7ee-6601-46ee-bd2f-5eaf0572e104
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 06, 2016
Package DI Number
08437014205251
Quantity per Package
2
Contains DI Package
08437014205244
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |