Identity
- Trade Name
- MacoPress Smarter FDA UDI
- Generic Name
- Blood component separator, automated FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- MacoPress Smart Smarter and DMS Ethernet Module - with breaker module FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- MAC2.BI.LAN FDA UDI
- Primary DI / UDI-DI
- 08033928530252 FDA UDI
- FDA Product Code
- KSS FDA UDI
- GMDN Term
- Blood component separator, automated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.9050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood component separator, automated
MacoPress Smarter by Delcon Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Delcon Srl
Sources (1)
- FDA UDI 5edcd375-c927-469b-ab71-84aa5d3706d1 34 fields · synced Jun 8, 2026