Duns Number:265492868
Device Description: The MacoMix HM20 device and optional Hemolog 6 software system is an automated blood mixer The MacoMix HM20 device and optional Hemolog 6 software system is an automated blood mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the preset target volume has been reached.
Catalog Number
9HHM-020-F
Brand Name
MacoMix HM20 and Hemolog 6
Version/Model Number
9HHM-020-F
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
BK160095
Product Code
MYJ
Product Code Name
Device, Mixing And Weighing, Semi-Automated
Public Device Record Key
8dab808c-8c21-4f61-987f-f914b9aa81fd
Public Version Date
August 30, 2018
Public Version Number
1
DI Record Publish Date
July 30, 2018
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |