Duns Number:440621212
Device Description: The MacoPress Smarter (MPS) and DMS consist of two parts: the MacoPress Smarter device and The MacoPress Smarter (MPS) and DMS consist of two parts: the MacoPress Smarter 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
MAC2.BR.WIFI
Brand Name
MacoPress Smarter
Version/Model Number
MacoPress Smart Smarter and DMS WIFI Module no breaker
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
April 30, 2030
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
23899883-56d2-48c8-9ee8-8a92471a3661
Public Version Date
December 24, 2021
Public Version Number
2
DI Record Publish Date
July 06, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |