Duns Number:557821760
Device Description: The Blood Collection Mixer CM735A is an automated blood mixing and weighing device used du The Blood Collection Mixer CM735A is an automated blood mixing and weighing device used during blood donation. The device provides efficient mixing of the whole blood collected with the anti-coagulant in the blood bag and automatically clamping the tube when the preset target volume is achieved. The mixer is powered by a rechargeable battery or AC power.
Catalog Number
CM735A
Brand Name
Blood Collection Mixer CM735A
Version/Model Number
CM735A
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KSQ
Product Code Name
Device, Blood Mixing And Blood Weighing
Public Device Record Key
3e787672-2fb6-45df-913e-2b749b65f37c
Public Version Date
April 13, 2020
Public Version Number
1
DI Record Publish Date
April 03, 2020
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 | 10 |