FDA UDI
In Commercial Distribution
🇺🇸 United States
CompoMat G5 Plus
DI: 04086000860161
·
Model: 9026561
·
Fresenius Kabi AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CompoMat G5 Plus
- Primary DI
- 04086000860161
- Version / Model
- 9026561
- Catalog Number
- 9026561
- Company Name
- Fresenius Kabi AG
- Labeler DUNS
- 315654579
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-07
- Public Version
- 1
- Public Version Date
- 2022-11-15
- Public Version Status
- New
- Public Device Record Key
- 00490fc3-d097-4bff-a5fb-d8f78d6583ce
Device Description
The CompoMat G5/ CompoMat G5 Plus/ CompoMaster Net G5 Plus system is intended to be used as an automatic blood component separator for blood component separation and processing.
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 | 04086000860161 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK190413 | 0 |