MILANO

GUDID 08033928530825

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

DELCON SRL

Blood donation rocker

• Primary Device ID: 08033928530825
• NIH Device Record Key: f07e8199-90e6-4af5-975c-883e394adff5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MILANO
• Version Model Number: HMIX4.31 Milano RFID version (white/grey)
• Company DUNS: 440621212
• Company Name: DELCON SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033928530825 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK190429

FDA Product Code

• MYJ: Device, Mixing And Weighing, Semi-Automated

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-11-04
• Device Publish Date: 2024-01-10

On-Brand Devices [MILANO]

• 08033928530832: HemoMix 4 is an automated blood monitor/mixer used during blood donation to mix the anti-coagula
• 08033928530825: HemoMix 4 is an automated blood monitor/mixer used during blood donation to mix the anti-coagula