Identity
- Trade Name
- MacoMix HM20 and Hemolog 6 FDA UDI
- Generic Name
- Blood donation rocker FDA UDI
- Device Name
- The MacoMix HM20 device and optional Hemolog 6 software system is an automated blood 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 preset target volume has been reached. FDA UDI
- Model / Reference
- 9HHM-020-F FDA UDI
- Description
- The MacoMix HM20 device and optional Hemolog 6 software system is an automated blood 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 preset target volume has been reached. FDA UDI
Identifiers
- Catalog Number
- 9HHM-020-F FDA UDI
- Primary DI / UDI-DI
- 03567051503227 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
MacoMix HM20 and Hemolog 6 by Maco Pharma — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood donation rocker.
- HemoMix 3 — DELCON SRL · Class II
- HemoMix 3 — DELCON SRL · 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
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
- Maco Pharma
Sources (1)
- FDA UDI 8dab808c-8c21-4f61-987f-f914b9aa81fd 36 fields · synced Jun 8, 2026