Duns Number:463625602
Device Description: DG Clean is a solution for cleaning the probes of Grifols analyzers.
Catalog Number
213797
Brand Name
DG Clean
Version/Model Number
213797
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
-
Product Code
JCB
Product Code Name
Detergent
Public Device Record Key
46116045-c00b-41e0-948f-3f5a6237b73a
Public Version Date
January 29, 2021
Public Version Number
1
DI Record Publish Date
January 21, 2021
Package DI Number
08436583730782
Quantity per Package
9
Contains DI Package
08436583730799
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |