FDA.reportPublic FDA data

MacoMix HM20 and Hemolog 6

Primary DI
03567051503227
Brand
MacoMix HM20 and Hemolog 6
Company
MACO PHARMA
Model
9HHM-020-F
Catalog number
9HHM-020-F
Device description
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.
Published
2018-07-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MYJDevice, Mixing And Weighing, Semi-Automated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYJDevice, Mixing And Weighing, Semi-AutomatedHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1600950

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1600950

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03567051503227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03567051503227035670515032273567051503227

GMDN Terms#

Term, Definition table
TermDefinition
Blood donation rockerA mains electricity (AC-powered), electromechanical device intended to maintain blood homogeneity through a continuous rocking motion. It is mostly used in a blood donor unit, department, or mobile unit, where the blood is kept in motion as it is drawn from the blood donor and runs into a blood donor bag or a set of collection tubes which lie in a cradle-like holder attached to this device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-270-6867CustomerCare@macopharmausa.com

Regulatory Flags#

DUNS number
577149081
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03567050035347LCG2b with AS-1, AS-3 and AS-5KSVKSV0004XD2016-09-22
03567050052740VSE3010XD - Empty Bag 300 mL 6-Way ManVSEVSE3010XD2016-09-22
03567050069687VSE8004XD - Empty Bag 600 mL 6-Way ManVSEVSE8004XD2016-09-22
03567050069908VQE2001XD - 4 Empty Bags 300 mLVQEVQE2001XD2016-09-22
03567050070317VSL7001PD - Therapeutic Phlebotomy Bag w/NeedleVSLVSL7001PD2016-09-22
03567050070324VSL7000YD - Therapeutic Phlebotomy BagVSLVSL7000YD2016-09-22
03567051503111VSE4002XD - Empty Bag 600 mLVSEVSE4002XD2016-09-22
03567051503128MRV6000LD - Therapeutic Phlebotomy Bag w/NeedleMRVMRV6000LD2016-09-22
03567050071970MacoSeal PS2-ASPS2-ASPS2-AS2022-12-31
03567050073097MACOSEAL LIGHT9MSLIGHT002024-08-27
035670515031669MPSBILAN:MacoPress Smart and DMS Ethernet Module-w/breaker for main press9MPSBILAN9MPSBILAN2018-06-19
035670515031739MPSBIWIFI:MacoPress Smart and DMS WiFi Module-with breaker for main press9MPSBIWIFI9MPSBIWIFI2018-06-19
035670515031809MPSBRLAN:MacoPress Smart and DMS Ethernet Module-no breaker9MPSBRLAN9MPSBRLAN2018-06-19
035670515031979MPSBRWIFI-MacoPress Smart and DMS WiFi Module-no breaker9MPSBRWIFI9MPSBRWIFI2018-06-19
035670515032039MPSBR485: MacoPress Smart and DMS RS485 Module-no breaker9MPSBR4859MPSBR4852018-06-19
035670515032109MPSBI485:MacoPress Smart and DMS RS485 Module-with breaker for main press9MPSBI4859MPSBI4852018-06-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033928530825MILANODELCON SRLMYJ2024-01-10
08033928530832MILANODELCON SRLMYJ2024-01-10
08033928530016HemoMix 3DELCON SRLMYJ2022-12-07
08033928530023HemoMix 3DELCON SRLMYJ2022-12-07
08033928530030HemoMix 3DELCON SRLMYJ2022-11-18
08033928530047HemoMix 3DELCON SRLMYJ2022-11-18
08033928530054HemoMix 3DELCON SRLMYJ2022-11-18
08033928530580HemoMix 4DELCON SRLMYJ2022-11-17
08033928530597HemoMix 4DELCON SRLMYJ2022-11-17
08033928530177HemoMix 4DELCON SRLMYJ2020-03-12
08033928530184HemoMix 4DELCON SRLMYJ2020-03-12
08033928530061HemoMix 3DELCON SRLMYJ2018-11-29