Home GUDID 04035479126391 Renamic PSA Module
Primary DI 04035479126391
Brand Renamic PSA Module
Company BIOTRONIK SE & Co. KG
Model 386610
Catalog number 386610
Published 2014-08-15
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name KRG Programmer, pacemaker
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KRG Programmer, Pacemaker Cardiovascular 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04035479126391 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04035479126391 04035479126391 4035479126391
GMDN Terms# Term, Definition table Term Definition Implantable pacemaker analyser, intraoperative An electronic instrument designed to test an implanted cardiac pacemaker, including the lead/tissue interface at the time of implantation, for invasive pacemaker evaluation and/or during electrophysiology (EP) diagnostic procedures. It has testing and recording capabilities to measure the minimum electrical stimulus needed to elicit ventricular contraction and the minimum intracardiac signal amplitude needed to inhibit the pacemaker (i.e., stimulation and sensing thresholds respectively). It typically includes measuring devices for the bioelectrical signals, a pulse generator, controllers, and the capability to test the characteristics and performance of the implanted pacemaker.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Storage Environment Atmospheric Pressure 0 0 Storage Environment Humidity 0 0 Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 315620229 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label false Expiration date on label false Donation ID number false Contains 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 04035479001575 M-50 BIOTRONIK SE & Co. KG KRG 2024-10-16 00763000842536 NA MEDTRONIC, INC. KRG 2023-11-11 20763000842530 NA MEDTRONIC, INC. KRG 2023-11-11 00763000181185 NA MEDTRONIC, INC. KRG 2023-01-30 04035479176112 DataBridge NA BIOTRONIK SE & Co. KG KRG 2022-12-14 00763000059545 Viva™ XT CRT-D MEDTRONIC, INC. KRG 2017-10-21 00763000059651 Viva™ Quad XT CRT-D MEDTRONIC, INC. KRG 2017-10-21 00763000059668 Viva™ XT CRT-D MEDTRONIC, INC. KRG 2017-10-21 00643169720138 Viva™ Quad XT CRT-D MEDTRONIC, INC. KRG 2017-09-15 00643169720145 Viva™ Quad S CRT-D MEDTRONIC, INC. KRG 2017-09-15 00643169720190 Viva™ Quad XT CRT-D MEDTRONIC, INC. KRG 2017-09-15 00643169720206 Viva™ Quad S CRT-D MEDTRONIC, INC. KRG 2017-09-15 00643169720251 Viva™ XT CRT-D MEDTRONIC, INC. KRG 2017-09-15 00643169720268 Viva™ S CRT-D MEDTRONIC, INC. KRG 2017-09-15 00643169720312 Viva™ XT CRT-D MEDTRONIC, INC. KRG 2017-09-15 00643169720329 Viva™ S CRT-D MEDTRONIC, INC. KRG 2017-09-15 00643169929319 Viva™ Quad XT CRT-D MEDTRONIC, INC. KRG 2017-05-22 00643169929371 Viva™ S CRT-D MEDTRONIC, INC. KRG 2017-05-22 00643169929388 Viva™ S CRT-D MEDTRONIC, INC. KRG 2017-05-22 00643169929395 Viva™ Quad S CRT-D MEDTRONIC, INC. KRG 2017-05-22 00643169929296 Viva™ XT CRT-D MEDTRONIC, INC. KRG 2017-05-14 00643169929302 Viva™ XT CRT-D MEDTRONIC, INC. KRG 2017-05-14 00643169929326 Viva™ Quad XT CRT-D MEDTRONIC, INC. KRG 2017-05-14 00643169929401 Viva™ Quad S CRT-D MEDTRONIC, INC. KRG 2017-05-14 05414734500449 SJM™ ST. JUDE MEDICAL, INC. KRG 2017-04-10 05414734006880 Identity™ ST. JUDE MEDICAL, INC. KRG 2017-02-06 05414734006774 Verity™ ST. JUDE MEDICAL, INC. KRG 2017-02-03 05414734006811 Verity™ ST. JUDE MEDICAL, INC. KRG 2017-02-03 05414734006835 Verity™ ST. JUDE MEDICAL, INC. KRG 2017-02-03 05414734006842 Verity™ ST. JUDE MEDICAL, INC. KRG 2017-02-03
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