Home GUDID 00899054002081 Sof-Flo Atraumatic Coronary Artery Shunt
Primary DI 00899054002081
Brand Sof-Flo Atraumatic Coronary Artery Shunt
Company KDL Medical, Inc.
Model SHT-1218S
Device description Vessel Shunt 1.75mm Tapered Tip, 12mm Shaft
Published 2017-03-14
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile true
Single use true
Product Codes# Code, Name table Code Name DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00899054002081 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00899054002081 00899054002081 899054002081 0899054002081
GMDN Terms# Term, Definition table Term Definition Surgical intravascular shunt A sterile device designed to temporarily channel (shunt) intravascular blood through a vascular anastomosis, primarily to control bleeding and enable distal perfusion during coronary or peripheral vascular bypass grafting and vessel repair surgery. It is typically designed as a hollow shaft with atraumatic dilations/bulbs on either end. The shaft is inserted into the lumen of the blood vessel via a small incision at the surgical site allowing blood to flow distal to the site of anastomosis. It is typically made of silicone elastomer and polyester radiopaque materials and is removed upon completion of the intervention. It is available in a range of diameters. This is a single-use device.
Regulatory Flags# DUNS number 791048924 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 true 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00803622104091 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-23 00803622104107 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-23 00803622104114 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-23 00803622104121 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-23 00803622104138 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-23 00803622104145 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-23 00803622104152 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-23 00803622104169 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-23 00803622105692 Venous cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-23 00803622104176 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104183 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104190 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104206 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104213 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104220 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104237 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104244 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104251 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104268 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104275 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104282 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104299 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104305 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104312 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104329 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104336 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104343 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104350 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104367 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17 00803622104374 Arterial cardiopulmonary bypass cannula LIVANOVA USA, INC. DWF 2015-07-17