Identity
- Trade Name
- HemoMix 3 FDA UDI
- Generic Name
- Blood donation rocker FDA UDI
- Device Name
- 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) FDA UDI
- Model / Reference
- HMIX3.485.RFID FDA UDI
- 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) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033928530023 FDA UDI
- FDA Product Code
- MYJ FDA UDI
- GMDN Term
- Blood donation rocker FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9195 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood donation rocker
HemoMix 3 by Delcon Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood donation rocker.
- MacoMix HM20 and Hemolog 6 — MACO PHARMA · Class II
- CompoGuard Complete (NA) — Fresenius Kabi · Class I
- Blood Collection Monitor CM350 — CENTRON CORPORATION · Class I
- Boekel Blood Collection Mixer — BOEKEL INDUSTRIES, INC. · Class I
- COMPOGUARD Advance Basic — Fresenius Kabi · Class I
- COMPOGUARD Advance COMPLETE — Fresenius Kabi · Class I
- Blood Collection Mixer CM735A — CENTRON CORPORATION · Class I
- Data Collection Mixer DCM3000 (BASIC) — CENTRON CORPORATION · Class I
Cleared under the same submission
BK180229 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Delcon Srl
Sources (1)
- FDA UDI c8341eb4-519d-4e89-80bd-a89b4a13dadd 34 fields · synced May 30, 2026