FDA UDI
In Commercial Distribution
🇺🇸 United States
Fenwal AMICUS RBC Set w/SEPACELL R-3000 RBC Leukocyte Reduction Filter
DI: M5264C23041
·
Model: 4C2304
·
Fresenius Kabi AG
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
3
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Fenwal AMICUS RBC Set w/SEPACELL R-3000 RBC Leukocyte Reduction Filter
- Primary DI
- M5264C23041
- Version / Model
- 4C2304
- Catalog Number
- 4C2304
- Company Name
- Fresenius Kabi AG
- Labeler DUNS
- 315654579
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2017-02-18
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- ef6f0186-371b-4ded-a6a9-1388d38cbb87
Device Description
For Filtration and Storage of One Unit of ACD-A/ADSOL Red Blood Cells. 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 |
|---|---|---|---|---|
| GKT | Separator, Automated, Blood Cell, Diagnostic | Hematology | 864.9245 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44903 | Blood transfer set | A collection of sterile, flexible, plastic tubing and associated items (e.g., couplers, adapters, clamps) used to transfer blood or blood components (e.g., peripheral stem cells, plasma) into containers or between containers for processing or storage (e.g., freezing). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M5264C23041 | HIBCC | ||||
| Unit of Use | M5264C23040 | HIBCC | ||||
| Package | M5264C23043 | HIBCC | Carton | 6 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK000039 | 0 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at Controlled Room Temperature. Protect from freezing. Avoid excessive heat.