Duns Number:440621212
Device Description: HemoMix 3 is an automated blood monitor/mixer used during blood donation to mix the anti-c HemoMix 3 is an automated blood monitor/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 target volume has been reached
Catalog Number
-
Brand Name
HemoMix 3
Version/Model Number
HMIX3.WIFI.RFID
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
November 29, 2028
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
MYJ
Product Code Name
Device, Mixing And Weighing, Semi-Automated
Public Device Record Key
a61690a2-2518-4a5c-86f3-842cbcc21770
Public Version Date
December 31, 2018
Public Version Number
1
DI Record Publish Date
November 29, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |