FDA.reportPublic FDA data

HemoMix 3

Primary DI
08033928530023
Brand
HemoMix 3
Company
DELCON SRL
Model
HMIX3.485.RFID
Device description
HemoMix 3 is an automated blood monitor/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 target volume has been reached (Version with internal RFID option installed)
Published
2022-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
BK1802290

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1802290

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033928530023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033928530023080339285300238033928530023

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

Regulatory Flags#

DUNS number
440621212
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033928530825MILANOHMIX4.31 Milano RFID version (white/grey)2024-01-10
08033928530832MILANOHMIX4.32 Milano standard version (white/grey)2024-01-10
08033928530016HemoMix 3HMIX3.4852022-12-07
08033928530061HemoMix 3HMIX3.WIFI.RFID2018-11-29
08033928530030HemoMix 3HMIX3.LAN2022-11-18
08033928530047HemoMix 3HMIX3.LAN.RFID2022-11-18
08033928530054HemoMix 3HMIX3.WIFI2022-11-18
08033928530580HemoMix 4HMIX4.21 RFID version (white/red shell)2022-11-17
08033928530597HemoMix 4HMIX4.22 standard version (white7red shell)2022-11-17
08033928530177HemoMix 4HMIX4.01 RFID version2020-03-12
08033928530184HemoMix 4HMIX4.02 standard version2020-03-12
08033928530498ROMA Cordless handheld sealer for blood bag tubingHWONE.012023-07-25
08033928530795ROMA ChargerACC0000662023-07-25
08033928530818HemoWeld-GunHWG2.002023-07-25
08033928530115HemoWeld-THWELD-T.DB.002022-12-07
08033928530122HemoWeld-GunHWG2.00H2022-12-07
08033928530139HemoWeld-GunHWG2.00V2022-12-07
08033928530146HemoWeld Gun HandgunHWG2.012022-12-07
08033928530153HemoWeld-BHWELD-B.DB.002022-12-07
08033928530160HemoWeld-SlimHWELDC.DB.002022-12-07

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
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
03567051503227MacoMix HM20 and Hemolog 6MACO PHARMAMYJ2018-07-30