MacoMix HM20 and Hemolog 6 9HHM-020-F

GUDID 03567051503227

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.

MACO PRODUCTIONS

Blood donation rocker
Primary Device ID03567051503227
NIH Device Record Key8dab808c-8c21-4f61-987f-f914b9aa81fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameMacoMix HM20 and Hemolog 6
Version Model Number9HHM-020-F
Catalog Number9HHM-020-F
Company DUNS265492868
Company NameMACO PRODUCTIONS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com
Phone770-270-6867
EmailCustomerCare@macopharmausa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103567051503227 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MYJDevice, Mixing And Weighing, Semi-Automated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-02-12
Device Publish Date2018-07-30

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