FDA UDI
In Commercial Distribution
🇺🇸 United States
CompoDock
DI: 04086000860215
·
Model: 9028721
·
Fresenius Kabi AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CompoDock
- Primary DI
- 04086000860215
- Version / Model
- 9028721
- Catalog Number
- 9028721
- 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
- 6acfbf22-f04b-43a2-9c26-b4ca67900e51
Device Description
The CompoDock is used for the production of special cellular blood components, e.g. in blood banks where tube connections are needed that provide protection against microbial contamination. The CompoDock is a high-frequency connection device that permits sterile connection of medical PVC tubes to one another. Here, sterile connection is achieved when germs from the environment are prevented from being carried into the closed systems. The closed system is maintained after the docking process.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| KSB | Set, Transfer (Blood/Plasma) | Hematology | 864.9875 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62054 | Laboratory tubing welder | A mains electricity (AC-powered) device intended to make a sterile connection (weld) between two segments of plastic tubing (typically blood transfer tubing during blood/blood component processing applications) in a clinical laboratory setting. It is a tabletop device which includes a blade, realignment mechanism, heating element and clamps intended to enable tubing dissection/reconnection while maintaining a closed system (sterile fluid path). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04086000860215 | GS1 |
Customer Contacts
- Phone
- +4961726868436
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK040076 | 0 |