Duns Number:265492868
Device Description: The MacoPress Smart (MPS) and DMS consist of two parts: the MacoPress Smart device and the The MacoPress Smart (MPS) and DMS consist of two parts: the MacoPress Smart device and the DMS Management software. The MacoPress Smart is intended as an automated blood component separator used for blood component separation and preparation. With the use of the DMS software, the separation procedures can be programmed to collect data of manufacturer components that can then be recorded, stored and analyzed.
Catalog Number
9MPSBI485
Brand Name
9MPSBI485:MacoPress Smart and DMS RS485 Module-with breaker for main press
Version/Model Number
9MPSBI485
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
KSS
Product Code Name
Supplies, Blood-Bank
Public Device Record Key
e487ee40-3338-4ac3-8a65-6044daa53c7d
Public Version Date
March 19, 2021
Public Version Number
2
DI Record Publish Date
June 19, 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 |