FDA.report

Fluency® Endovascular Stent Graft

Primary DI
04049519008523
Brand
Fluency® Endovascular Stent Graft
Company
Bard Peripheral Vascular, Inc.
Model
FEM08120
Catalog number
FEM08120
Device description
FLUENCY® PLUS Endovascular Stent Graft 8 mm x 120 mm (80 cm delivery system)
Published
2014-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

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

Product Code Classifications

CodeDeviceSpecialtyClass
PFVSystem, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis TreatmentUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049519008523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049519008523040495190085234049519008523

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling

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

Contacts

PhoneEmail
+1(800)321-4254medical.services@crbard.com

Regulatory Flags

DUNS number
135057938
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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