FDA UDI
In Commercial Distribution
🇺🇸 United States
Fluency® Endovascular Stent Graft
DI: 04049519008509
·
Model: FEM08080
·
Bard Peripheral Vascular, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Fluency® Endovascular Stent Graft
- Primary DI
- 04049519008509
- Version / Model
- FEM08080
- Catalog Number
- FEM08080
- Company Name
- Bard Peripheral Vascular, Inc.
- Labeler DUNS
- 135057938
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-19
- Public Version
- 8
- Public Version Date
- 2024-11-25
- Public Version Status
- Update
- Public Device Record Key
- 18920a65-3837-4a2a-b98e-c032458d367d
Device Description
FLUENCY® PLUS Endovascular Stent Graft 8 mm 80 mm (80 cm delivery system)
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
- Yes
- MRI Safety
- MR Conditional
- 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 |
|---|---|---|---|---|
| PFV | System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61856 | Central/peripheral venous endovascular stent-graft | A non-bioabsorbable tubular device designed to be implanted in a central and/or peripheral vein (e.g., subclavian, brachiocephalic) to maintain vessel lumen patency, typically to treat stenosis in the outflow of an arteriovenous fistula (AVF) or graft used for haemodialysis; it is not intended for coronary or intracranial venous stenting. It is a mesh structure made of metal [e.g., nickel-titanium alloy] that is covered with a synthetic polymer [e.g., polytetrafluoroethylene (ePTFE)] membrane (endovascular graft), and contains an inner carbon coating to help prevent platelet adhesion. It is typically expanded in situ and disposable devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049519008509 | GS1 |
Customer Contacts
- Phone
- +1(800)321-4254
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Implant Diameter,8 Millimeter | ||
| Device Size Text, specify | Catheter Length,80 Centimeter | ||
| Device Size Text, specify | Implant Length,80 Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool (room temperature), dry place