FDA.reportPublic FDA data

MILANO

Primary DI
08033928530825
Brand
MILANO
Company
DELCON SRL
Model
HMIX4.31 Milano RFID version (white/grey)
Device description
HemoMix 4 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
Published
2024-01-10
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
BK1904290

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1904290

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033928530825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033928530825080339285308258033928530825

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
08033928530832MILANOHMIX4.32 Milano standard version (white/grey)2024-01-10
08033928530016HemoMix 3HMIX3.4852022-12-07
08033928530023HemoMix 3HMIX3.485.RFID2022-12-07
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
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
03567051503227MacoMix HM20 and Hemolog 6MACO PHARMAMYJ2018-07-30