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 (Basic version)) FDA UDI
- Model / Reference
- HMIX3.485 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 (Basic version)) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033928530016 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 f7010046-f270-434e-b4f1-7140929edf1e 34 fields · synced May 29, 2026