FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Flair® Endovascular Stent Graft
DI: 04049519008868
·
Model: FAF09040
·
Bard Peripheral Vascular, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Flair® Endovascular Stent Graft
- Primary DI
- 04049519008868
- Version / Model
- FAF09040
- Catalog Number
- FAF09040
- Company Name
- Bard Peripheral Vascular, Inc.
- Labeler DUNS
- 135057938
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-19
- Public Version
- 10
- Public Version Date
- 2024-12-11
- Public Version Status
- Update
- Public Device Record Key
- c48c2f96-fad9-4e0d-98bb-eb9cccf39aa3
- Distribution End Date
- 2022-05-10
Device Description
FLAIR® Endovascular Stent Graft 9 mm x 40 mm (80 cm delivery catheter)(flared)
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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 43526 | Peripheral artery endovascular stent-graft, non-medicated | A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to maintain patency and improve luminal diameter, typically in patients with symptomatic peripheral vascular disease or following the recanalization of a total occlusion. It may be intended for implantation in an artery adjacent to the aorta (e.g., iliac, renal), however it is not a dedicated component of an aortoiliac stent-graft assembly; it may additionally be intended for venous implantation. It is a metallic mesh-like structure with a synthetic polymer tube (endovascular graft); it does not include pharmaceuticals. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049519008868 | GS1 | ||||
| Package | 14049519008865 | GS1 | Other | 1 | Not in Commercial Distribution | 2022-05-10 |
Customer Contacts
- Phone
- +1(800)321-4254
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P060002 | 000 |
| P060002 | 001 |
| P060002 | 002 |
| P060002 | 006 |
| P060002 | 011 |
| P060002 | 034 |
| P060002 | 038 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Implant Diameter,9 Millimeter | ||
| Device Size Text, specify | Catheter Length,80 Centimeter | ||
| Device Size Text, specify | Implant Length,40 Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect the packaged product from direct sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool (room temperature), dry place