FDA UDI
In Commercial Distribution
🇺🇸 United States
Fenwal PlasmaLink Transfer-Pack Container with Luer Adapter and No Outlet Ports
DI: 14086000101414
·
Model: 4R2088P
·
Fresenius Kabi AG
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
Basic Information
- Brand Name
- Fenwal PlasmaLink Transfer-Pack Container with Luer Adapter and No Outlet Ports
- Primary DI
- 14086000101414
- Version / Model
- 4R2088P
- Catalog Number
- 4R2088P
- Company Name
- Fresenius Kabi AG
- Labeler DUNS
- 315654579
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-09-02
- Public Version
- 4
- Public Version Date
- 2023-02-20
- Public Version Status
- Update
- Public Device Record Key
- 0ef14dc0-19cc-4c38-9acc-110017e8f537
Device Description
For processing and/or storage of blood or blood components. 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 |
|---|---|---|---|---|
| KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | Hematology | 864.9100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44904 | Blood/tissue storage/culture container | A receptacle intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 14086000101414 | GS1 | ||||
| Unit of Use | 04086000101417 | GS1 | ||||
| Package | 24086000101411 | GS1 | Carton | 4 | In Commercial Distribution |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at Room Temperature. Protect from freezing. Avoid excessive heat.