FDA.reportPublic FDA data

MacoPress Smarter

Primary DI
08033928530269
Brand
MacoPress Smarter
Company
DELCON SRL
Model
MacoPress Smart Smarter and DMS WIFI Module no bre
Catalog number
MAC2.BR.WIFI
Device description
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.
Published
2020-07-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KSSSupplies, Blood-Bank

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSSSupplies, Blood-BankHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033928530269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033928530269080339285302698033928530269

GMDN Terms#

Term, Definition table
TermDefinition
Blood component separator, automatedA mains electricity (AC-powered) device designed for the automated separation of whole blood or previously centrifuged blood into components [e.g., red blood cells (RBCs), platelets, leukocytes] for further processing or storage. It is a programmable device with a user interface that uses a mechanical separation method (e.g., pressure plates, microfluidics) to transfer the blood component(s) from the donor bag into a removable disposable receptacle. It may have additional features such as sensors, scales, and an automatic mechanism for opening the valve(s) on the donor bag. It is typically used in a blood bank or transfusion centre, and is not donor or patient connected.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
440621212
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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08033928530825MILANOHMIX4.31 Milano RFID version (white/grey)2024-01-10
08033928530832MILANOHMIX4.32 Milano standard version (white/grey)2024-01-10
08033928530016HemoMix 3HMIX3.4852022-12-07
08033928530023HemoMix 3HMIX3.485.RFID2022-12-07
08033928530061HemoMix 3HMIX3.WIFI.RFID2018-11-29
08033928530030HemoMix 3HMIX3.LAN2022-11-18
08033928530047HemoMix 3HMIX3.LAN.RFID2022-11-18
08033928530054HemoMix 3HMIX3.WIFI2022-11-18
08033928530580HemoMix 4HMIX4.21 RFID version (white/red shell)2022-11-17
08033928530597HemoMix 4HMIX4.22 standard version (white7red shell)2022-11-17
08033928530177HemoMix 4HMIX4.01 RFID version2020-03-12
08033928530184HemoMix 4HMIX4.02 standard version2020-03-12
08033928530498ROMA Cordless handheld sealer for blood bag tubingHWONE.012023-07-25
08033928530795ROMA ChargerACC0000662023-07-25
08033928530818HemoWeld-GunHWG2.002023-07-25
08033928530115HemoWeld-THWELD-T.DB.002022-12-07
08033928530122HemoWeld-GunHWG2.00H2022-12-07
08033928530139HemoWeld-GunHWG2.00V2022-12-07
08033928530146HemoWeld Gun HandgunHWG2.012022-12-07
08033928530153HemoWeld-BHWELD-B.DB.002022-12-07

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Primary DI, Brand, Company table
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20812269031275TypesafeTYPENEX MEDICAL LLCKSS2022-11-21
00812269031295TypesafeTYPENEX MEDICAL LLCKSS2022-11-21
10810020440536Hematype Segment DeviceFresenius Kabi AGKSS2022-11-08
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