Duns Number:557821760
Device Description: The Data Collection Mixer DCM3000 is an electromechanical blood mixing and weighing device The Data Collection Mixer DCM3000 is an electromechanical blood mixing and weighing device intended to maintain blood homogeneity during blood donation, and automatically clamps tubing when target volume is achieved equipped with convenient as barcode reading and remote control system. The mixer has two operation modes, DATA mode and BASIC mode and operates on dual power sources- AC power adaptor and the rechargeable battery pack.
Catalog Number
CM760
Brand Name
Data Collection Mixer DCM3000 (BASIC)
Version/Model Number
DCM3000B
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
f8ff7b06-a77d-4e4c-9935-653b313ad06e
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 |