FDA.reportPublic FDA data

BARD® BRENER

Primary DI
10801741090124
Brand
BARD® BRENER
Company
Bard Peripheral Vascular, Inc.
Model
007755
Catalog number
007755
Device description
BARD® BRENER™ Carotid Bypass Shunt, Tapered Carotid Shunt With Side Arm, 14F-8F x 13cm
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741090124PackageGS15In Commercial Distribution
00801741090127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174109012410801741090124
00801741090127008017410901278017410901270801741090127

GMDN Terms#

Term, Definition table
TermDefinition
Carotid artery shuntA sterile device designed to serve as a temporary blood conduit (a shunt) connecting the distal internal carotid artery to the proximal common carotid artery allowing intravascular blood to continuously flow to the patient's brain during an endarterectomy procedure. It is typically designed as a hollow shaft with atraumatic dilations (e.g., balloons) on either end. The shaft is inserted into the lumen of the blood vessel, via a small incision at the surgical site. It is typically made of silicone elastomer and polyester radiopaque materials and is available in a range of diameters. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length13Centimeter

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
DM exempt
false
Premarket exempt
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741234187EnCor EnCompass™ENCPBagENCPBag2026-02-09
10801741234153EnCor EnCompass™ENCPSCENCPSC2026-02-04
10801741234160EnCor EnCompass™ENCPMRIXENCPMRIX2026-02-04
00801741236167EnCor EnCompass™ENCP10GVLOCENCP10GVLOC2026-02-04
00801741234194EnCor EnCompass™ENCPSTENCPST2026-02-03
00801741234248EnCor EnCompass™ENCPDriverENCPDriver2026-02-03
00801741234262EnCor EnCompass™ENCPFSENCPFS2026-02-03
00801741235221EnCor EnCompass™ENCPConsoleENCPConsole2026-02-03
10801741234092EnCor EnCompass™ENCP7GENCP7G2026-01-30
10801741234139EnCor EnCompass™ENCP7GBTENCP7GBT2026-01-30
00801741234200EnCor EnCompass™ENCP7GVLOCENCP7GVLOC2026-01-30
10801741234115EnCor EnCompass™ENCP12GENCP12G2026-01-28
10801741234146EnCor EnCompass™ENCP10GBTENCP10GBT2026-01-28
10801741234177EnCor EnCompass™ENCP10GENCP10G2026-01-28
10801741226332UltraCor™ Twirl™UCLS17UCLS172025-04-01
10801741226349UltraCor™ Twirl™UCVR17UCVR172025-04-01
10801741230605PeritX90-201090-20102025-01-23
10801741230612PeritX90-200590-20052025-01-23
10801741230636PeritX90-202090-20202025-01-23
50885403464032JamshidiEJC3513EJC35132017-10-02

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20199150072020NAMEDTRONIC, INC.DWF2026-03-07
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00199150072040NAMEDTRONIC, INC.DWF2026-03-07