FDA UDI
In Commercial Distribution
🇺🇸 United States
HemoMix 3
DI: 08033928530047
·
Model: HMIX3.LAN.RFID
·
DELCON SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- HemoMix 3
- Primary DI
- 08033928530047
- Version / Model
- HMIX3.LAN.RFID
- Company Name
- DELCON SRL
- Labeler DUNS
- 440621212
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-18
- Public Version
- 4
- Public Version Date
- 2026-01-12
- Public Version Status
- Update
- Public Device Record Key
- d6eff926-9e18-4c06-8721-0d2a81e330f5
Device 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 LAN and integrated RFID options installed)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MYJ | Device, Mixing And Weighing, Semi-Automated | Hematology | 864.9195 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36405 | Blood donation rocker | An electromechanical device intended to be used during a blood donation procedure to agitate collected blood 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 (not included) which lie in a cradle-like holder. Additionally, it will typically be designed to weigh the collected blood, and may feature electronic controls for operating a clamping mechanism to secure blood collection tubing and stop/restart blood drawing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033928530047 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK180229 | 0 |