Flair® Endovascular Stent Graft

Primary DI
04049519008851
Brand
Flair® Endovascular Stent Graft
Company
Bard Peripheral Vascular, Inc.
Model
FAF09030
Catalog number
FAF09030
Device description
FLAIR® Endovascular Stent Graft 9 mm x 30 mm (80 cm delivery catheter)(flared)
Published
2014-09-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
PFVSystem, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIHSystem, Endovascular Graft, Aortic Aneurysm TreatmentUnknown3
PFVSystem, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis TreatmentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P060002000
P060002001
P060002002
P060002006
P060002011
P060002034
P060002038

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P060002000FLAIR ENDOVASCULAR STENT GRAFTBard Peripheral Vascular2007-07-23PFV
P060002001FLAIR ENDOVASCULAR STENT GRAFTBard Peripheral Vascular2007-07-23PFV
P060002002FLAIR ENDOVASCULAR STENT GRAFTBard Peripheral Vascular2007-07-23PFV
P060002006FLAIR ENDOVASCULAR STENT GRAFTBard Peripheral Vascular2007-07-23PFV
P060002011FLAIR ENDOVASCULAR STENT GRAFTBard Peripheral Vascular2007-07-23PFV
P060002034FLAIR ENDOVASCULAR STENT GRAFTBard Peripheral Vascular2007-07-23PFV
P060002038FLAIR ENDOVASCULAR STENT GRAFTBard Peripheral Vascular2007-07-23PFV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14049519008858PackageGS11Not in Commercial Distribution
04049519008851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1404951900885814049519008858
04049519008851040495190088514049519008851

GMDN Terms#

Term, Definition table
TermDefinition
Iliofemoral artery endovascular stent-graftA sterile non-bioabsorbable tubular device intended to be implanted in the iliac and, alternatively, superficial femoral arteries to reline tortuous arteries in patients with symptomatic peripheral vascular disease (PVD). It is percutaneously inserted via the femoral artery to the site of implantation, with a disposable delivery device, where it self-expands. It is typically made of nickel-titanium alloy (Nitinol) that forms an outer mesh structure with an inner polymer tube (endovascular graft). It is available in a variety of lengths and diameters. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Protect the packaged product from direct sunlight
Special Storage Condition, Specify00Store in a cool (room temperature), dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)321-4254medical.services@crbard.com

Regulatory Flags#

DUNS number
135057938
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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