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9MPSBILAN:MacoPress Smart and DMS Ethernet Module-w/breaker for main press
FDA UDIClass I (US FDA UDI)
by Maco Pharma
Identity
- Trade Name
- 9MPSBILAN:MacoPress Smart and DMS Ethernet Module-w/breaker for main press FDA UDI
- Generic Name
- Blood component separator, automated FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 9MPSBILAN FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 9MPSBILAN FDA UDI
- Primary DI / UDI-DI
- 03567051503166 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
9MPSBILAN:MacoPress Smart and DMS Ethernet Module-w/breaker for main press by Maco Pharma — Class I — FDA UDI — listed in FDA GUDID
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- MacoPress Smarter — DELCON SRL · Class I
- 9MPSBIWIFI:MacoPress Smart and DMS WiFi Module-with breaker for main press — MACO PHARMA · Class I
- 9MPSBR485: MacoPress Smart and DMS RS485 Module-no breaker — MACO PHARMA · Class I
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
- Maco Pharma
Sources (1)
- FDA UDI 9043b4ca-1be9-4c4e-a296-f404e180bf70 35 fields · synced May 31, 2026