FDA.reportPublic FDA data

MACO PHARMA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30044043233004404323MACO PHARMA1N2026-01-01233 RUE LORTHIOIS -- MOUVAUX Hauts-de-France FR 59420

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
03567050035347LCG2b with AS-1, AS-3 and AS-5 - Leucolab LCG2b Leukoreduction System for Red Blood Cells. The Leucolab LCG2b product consists of a transfer line, drip chamber, leukoreduction filter, by-pass tubing and transfer bag. It is sterilized by electron beam (beta irradiation) and is supplied with sterile and non-pyrogenic fluid pathways.770-270-6867CustomerCare@MacopharmaUSA.com
03567050052740VSE3010XD - Empty Bag 300 mL 6-Way Man - 300 mL Empty Bag for Pooling of Blood Components.770-270-6867CustomerCare@MacopharmaUSA.com
03567050069687VSE8004XD - Empty Bag 600 mL 6-Way Man - 600 mL Empty Bag for Pooling of Blood Components.770-270-6867CustomerCare@MacopharmaUSA.com
03567050069908VQE2001XD - 4 Empty Bags 300 mL - 300ml Quad Splitting Empty Bags.770-270-6867CustomerCare@MacopharmaUSA.com
03567050070317VSL7001PD - Therapeutic Phlebotomy Bag w/Needle - 600 mL Phlebotomy Bag with Needle.770-270-6867CustomerCare@MacopharmaUSA.com
03567050070324VSL7000YD - Therapeutic Phlebotomy Bag - 600 mL Phlebotomy Bag with Luer Lock.770-270-6867CustomerCare@MacopharmaUSA.com
03567051503111VSE4002XD - Empty Bag 600 mL - 600 mL Empty Bag.770-270-6867CustomerCare@MacopharmaUSA.com
03567051503227MacoMix HM20 and Hemolog 6 - The MacoMix HM20 device and optional Hemolog 6 software system is an automated blood mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the preset target volume has been reached.770-270-6867CustomerCare@macopharmausa.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submission
3352921213232986BK180306
3352921267486689BK170085
3352921357829529BK160095
3352921745481640BK120071
3352921494298122BK030008
3352922042485324

GUDID#

9MPSBILAN:MacoPress Smart and DMS Ethernet Module-w/breaker for main press - 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.

MACO PHARMA

2018-06-19

9MPSBIWIFI:MacoPress Smart and DMS WiFi Module-with breaker for main press - 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.

MACO PHARMA

2018-06-19

9MPSBI485:MacoPress Smart and DMS RS485 Module-with breaker for main press - 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.

MACO PHARMA

2018-06-19