AccessGUDID - DEVICE: BARD® (00801741090158)

GUDID

Device Identifier (DI) Information

Brand Name: BARD®
Version or Model: S11885004
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: S11885004
Company Name: Bard Peripheral Vascular, Inc.

Primary DI Number: 00801741090158
Issuing Agency: GS1
Commercial Distribution End Date: November 30, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 135057938 *Terms of Use

Device Description: BARD® Carotid Bypass Shunt, Straight Carotid Shunt, 8F x 13cm

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
47113	Carotid artery shunt	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWF	CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 13 Centimeter
Device Size Text, specify: External Diameter - 8 French

Device Record Status

Public Device Record Key: a3c4f32b-73fc-4695-989b-31d2631ad688
Public Version Date: April 17, 2024
Public Version Number: 3
DI Record Publish Date: September 19, 2016