FDA UDI
In Commercial Distribution
🇺🇸 United States
AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector
DI: 04086000100953
·
Model: X6R2301
·
Fresenius Kabi AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector
- Primary DI
- 04086000100953
- Version / Model
- X6R2301
- Catalog Number
- X6R2301
- Company Name
- Fresenius Kabi AG
- Labeler DUNS
- 315654579
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-23
- Public Version
- 1
- Public Version Date
- 2020-07-01
- Public Version Status
- New
- Public Device Record Key
- 4c7108ab-6000-4d09-a19e-fdd2107b5bb8
Device Description
AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector
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 |
|---|---|---|---|---|
| GKT | Separator, Automated, Blood Cell, Diagnostic | Hematology | 864.9245 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47572 | Apheresis system tubing set | A collection of sterile, flexible, plastic tube segments and associated items (e.g., connectors, line clamp, drip chamber) intended to be used in an apheresis system to channel blood from the patient to an appropriate apheresis column before being returned to the patient. It creates a closed-circuit for the extracorporeal removal of a constituent of whole blood (e.g., leukocytes, plasma). The channeling of apheresis solutions for the priming, regeneration, preservation of columns before or after an apheresis procedure may also be through the tubing set. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14086000100950 | GS1 | Carton | 6 | In Commercial Distribution | |
| Primary | 04086000100953 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK160112 | 0 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storage and Handling as defined on label