FDA.reportPublic FDA data

Fluency® Endovascular Stent Graft

Primary DI
04049519008257
Brand
Fluency® Endovascular Stent Graft
Company
Bard Peripheral Vascular, Inc.
Model
FEL10080
Catalog number
FEL10080
Device description
FLUENCY® PLUS Endovascular Stent Graft 10 mm x 80 mm (117 cm delivery system)
Published
2014-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PFVSystem, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049519008257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049519008257040495190082574049519008257

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, 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
Expiration date on label
true
No natural rubber latex
true

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00801741032134SenoMark® Ultra Breast Tissue MarkerSMEV9RSMEV9R2015-10-02
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00801741032226UltraClip® Dual Trigger Breast Tissue Marker862017DL862017DL2015-09-25
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Primary DI, Brand, Company table
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