FDA UDI
In Commercial Distribution
🇺🇸 United States
HemoMix 3
DI: 08033928530016
·
Model: HMIX3.485
·
DELCON SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- HemoMix 3
- Primary DI
- 08033928530016
- Version / Model
- HMIX3.485
- Company Name
- DELCON SRL
- Labeler DUNS
- 440621212
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-07
- Public Version
- 3
- Public Version Date
- 2026-01-12
- Public Version Status
- Update
- Public Device Record Key
- f7010046-f270-434e-b4f1-7140929edf1e
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 (Basic version))
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 | 08033928530016 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK180229 | 0 |