FDA UDI
In Commercial Distribution
🇺🇸 United States
MacoMix HM20 and Hemolog 6
DI: 03567051503227
·
Model: 9HHM-020-F
·
MACO PRODUCTIONS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MacoMix HM20 and Hemolog 6
- Primary DI
- 03567051503227
- Version / Model
- 9HHM-020-F
- Catalog Number
- 9HHM-020-F
- Company Name
- MACO PRODUCTIONS
- Labeler DUNS
- 265492868
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-30
- Public Version
- 1
- Public Version Date
- 2018-08-30
- Public Version Status
- New
- Public Device Record Key
- 8dab808c-8c21-4f61-987f-f914b9aa81fd
Device 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.
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 | A mains electricity (AC-powered), electromechanical device intended to maintain blood homogeneity 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 which lie in a cradle-like holder attached to this device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03567051503227 | GS1 |
Customer Contacts
- Phone
- 770-270-6867
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK160095 | 0 |