Home GUDID 10846835026795
Dual Energy Thermocool Smarttouch SF Catheter
Primary DI 10846835026795
Brand Dual Energy Thermocool Smarttouch SF Catheter
Company Biosense Webster Inc
Model D134811
Catalog number D134811
Device description THMCL SMTCH SF DE, BI,TC, D-D
Published 2026-07-09
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile true
Single use true
Product Codes# Code, Name table Code Name OAD catheter, percutaneous, cardiac ablation, for treatment of atrial flutter OAE Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation QZI Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown 3 OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown 3 QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10846835026795 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10846835026795 10846835026795
GMDN Terms# Term, Definition table Term Definition Cardiac irreversible electroporation system catheter A flexible tube with an electrode array its distal end designed to be used as part of a cardiac irreversible electroporation system to apply a series of microsecond electrical pulses to ablate endocardial tissues through irreversible electroporation, to treat cardiac arrhythmia. It is typically also intended to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping. It is designed to be introduced into the heart via venous access (e.g., femoral vein). This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Do not use if package is damaged Special Storage Condition, Specify 0 0 Keep Dry Special Storage Condition, Specify 0 0 Keep out of direct sunlight Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 020163218 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 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 10846835026726 Dual Energy Thermocool Smarttouch SF Catheter Biosense Webster Inc OAE 2026-07-09 10846835026726 Dual Energy Thermocool Smarttouch SF Catheter Biosense Webster Inc QZI 2026-07-09 10846835026726 Dual Energy Thermocool Smarttouch SF Catheter Biosense Webster Inc OAD 2026-07-09 10846835026733 Dual Energy Thermocool Smarttouch SF Catheter Biosense Webster Inc OAD 2026-07-09 10846835026733 Dual Energy Thermocool Smarttouch SF Catheter Biosense Webster Inc OAE 2026-07-09 10846835026733 Dual Energy Thermocool Smarttouch SF Catheter Biosense Webster Inc QZI 2026-07-09 10846835026764 Dual Energy Thermocool Smarttouch SF Catheter Biosense Webster Inc QZI 2026-07-09 10846835026764 Dual Energy Thermocool Smarttouch SF Catheter Biosense Webster Inc OAD 2026-07-09 10846835026764 Dual Energy Thermocool Smarttouch SF Catheter Biosense Webster Inc OAE 2026-07-09 10846835026825 Dual Energy Thermocool Smarttouch SF Catheter Biosense Webster Inc OAE 2026-07-09 10846835026825 Dual Energy Thermocool Smarttouch SF Catheter Biosense Webster Inc OAD 2026-07-09 10846835026825 Dual Energy Thermocool Smarttouch SF Catheter Biosense Webster Inc QZI 2026-07-09 10846835026856 Dual Energy Thermocool Smarttouch SF Catheter Biosense Webster Inc QZI 2026-07-09 10846835026856 Dual Energy Thermocool Smarttouch SF Catheter Biosense Webster Inc OAD 2026-07-09 10846835026856 Dual Energy Thermocool Smarttouch SF Catheter Biosense Webster Inc OAE 2026-07-09 10846835026887 Dual Energy Thermocool Smarttouch SF Catheter Biosense Webster Inc OAE 2026-07-09 10846835026887 Dual Energy Thermocool Smarttouch SF Catheter Biosense Webster Inc QZI 2026-07-09 10846835026887 Dual Energy Thermocool Smarttouch SF Catheter Biosense Webster Inc OAD 2026-07-09 10846835026917 Dual Energy Thermocool Smarttouch SF Catheter Biosense Webster Inc QZI 2026-07-09 10846835026917 Dual Energy Thermocool Smarttouch SF Catheter Biosense Webster Inc OAD 2026-07-09 10846835026917 Dual Energy Thermocool Smarttouch SF Catheter Biosense Webster Inc OAE 2026-07-09 00763000954321 NA MEDTRONIC, INC. QZI 2026-04-30 00763000954321 NA MEDTRONIC, INC. OAD 2026-04-30 00763000954321 NA MEDTRONIC, INC. OAE 2026-04-30 05415067052933 Current™ ST. JUDE MEDICAL, INC. QZI 2026-04-20 05415067053893 Current™ ST. JUDE MEDICAL, INC. QZI 2026-04-20 05415067056009 Volt™ ST. JUDE MEDICAL, INC. QZI 2026-02-25 05415067056016 Volt™ ST. JUDE MEDICAL, INC. QZI 2026-02-25 05415067056023 Volt™ ST. JUDE MEDICAL, INC. QZI 2026-02-25 05415067056030 Volt™ ST. JUDE MEDICAL, INC. QZI 2026-02-25