AccessGUDID - DEVICE: Flair® Endovascular Stent Graft (04049519008912)

GUDID

Device Identifier (DI) Information

Brand Name: Flair® Endovascular Stent Graft
Version or Model: FAS06050
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FAS06050
Company Name: Bard Peripheral Vascular, Inc.

Primary DI Number: 04049519008912
Issuing Agency: GS1
Commercial Distribution End Date: May 10, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 135057938 *Terms of Use

Device Description: FLAIR® Endovascular Stent Graft 6 mm x 50 mm (80 cm delivery catheter)(straight)

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
43526	Peripheral artery endovascular stent-graft, non-medicated	A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes coronary 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 in addition be intended for optional venous implantation. It does not include anticoagulant or antiproliferative pharmaceuticals. It is a metallic outer mesh-like structure with an inner synthetic polymer tube (endovascular graft) available in various sizes. It is percutaneously inserted with a disposable delivery device which may be included with the stent-graft.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PFV	System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P060002	000
P060002	001
P060002	002
P060002	006
P060002	011
P060002	034
P060002	038

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Store in a cool (room temperature), dry place
Special Storage Condition, Specify: Protect the packaged product from direct sunlight
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Implant Diameter,6 Millimeter
Device Size Text, specify: Implant Length,50 Millimeter
Device Size Text, specify: Catheter Length,80 Centimeter

Device Record Status

Public Device Record Key: 585ee4c9-cc01-486b-a618-17475080119c
Public Version Date: February 03, 2023
Public Version Number: 8
DI Record Publish Date: September 19, 2014