FDA UDI
In Commercial Distribution
🇺🇸 United States
AMICUS Exchange Kit
DI: 04086000100151
·
Model: X6R2339
·
Fresenius Kabi AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- AMICUS Exchange Kit
- Primary DI
- 04086000100151
- Version / Model
- X6R2339
- Catalog Number
- X6R2339
- Company Name
- Fresenius Kabi AG
- Labeler DUNS
- 315654579
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-05
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 00c008cf-c68d-4a80-abb8-da5b90a910a0
Device Description
For Therapeutic Plasma Exchange (TPE) Procedure. For Use with the AMICUS Separator. Sterile Fluid Path.
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46998 | Therapeutic plasma/red blood cell exchange tubing set | A disposable collection of devices intended to be used in a therapeutic plasma exchange (TPE) or red blood cell exchange system. It typically consists of tubing, solution lines, connection ports, a filter membrane and collection containers (bags) to channel blood from the patient through the extracorporeal circuit to remove a disease-mediating blood component. The blood is returned to the patient with any substitution products. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04086000100151 | GS1 | ||||
| Package | 14086000100158 | GS1 | Carton | 6 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111702 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at Room Temperature. Protect from freezing. Avoid excessive heat.