FDA UDI
In Commercial Distribution
🇺🇸 United States
CompoMat G5
DI: 04086000860475
·
Model: 9025561
·
Fresenius Kabi AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CompoMat G5
- Primary DI
- 04086000860475
- Version / Model
- 9025561
- Catalog Number
- 9025561
- Company Name
- Fresenius Kabi AG
- Labeler DUNS
- 315654579
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 4
- Public Version Date
- 2018-09-03
- Public Version Status
- Update
- Public Device Record Key
- 32e1dad2-6fae-491b-a83a-2c6d08b39fc9
Device Description
The CompoMat G5 / CompoMaster Net G5 System is intended as an automated blood component separator used for blood component separation and preparation. The CompoMat G5 can carry out almost all preparation methods and handle almost all blood bag systems, such as conventional double, triple and quadruple blood bag systems.
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 |
|---|---|---|---|---|
| KSS | Supplies, Blood-Bank | Hematology | 864.9050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61618 | Blood component separator, automated | A mains electricity (AC-powered) device designed for the automated separation of whole blood or previously centrifuged blood into components [e.g., red blood cells (RBCs), platelets, leukocytes] for further processing or storage. It is a programmable device with a user interface that uses a mechanical separation method (e.g., pressure plates, microfluidics) to transfer the blood component(s) from the donor bag into a removable disposable receptacle. It may have additional features such as sensors, scales, and an automatic mechanism for opening the valve(s) on the donor bag. It is typically used in a blood bank or transfusion centre, and is not donor or patient connected. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04086000860475 | GS1 |
Customer Contacts
- Phone
- +4961726868436
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK110012 | 0 |