Home GUDID H758516004 Integrity®
Primary DI H758516004
Brand Integrity®
Company ST. JUDE MEDICAL, INC.
Model ADx SR
Catalog number 5160
Device description Pulse Generator SSIR
Published 2014-10-25
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true 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 05414734006781 Primary GS1 0 H758516004 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05414734006781 05414734006781 5414734006781
GMDN Terms# Term, Definition table Term Definition Single-chamber implantable pacemaker, rate-responsive A sterile, battery-powered device consisting of a hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with a pacing lead in or on one chamber of the heart (right atrium or ventricle). It is intended to generate and conduct electrical impulses to an abnormal heart to adjust its rate of contraction to meet the body's increased need for blood flow due to activity. It contains one or more sensors to detect changes in the body (e.g., motion, breathing frequency) to indicate more oxygen is needed, and subsequently increases the pacing rate; it is not intended to provide defibrillation therapy.
Device Sizes# Type, Value, Unit table Type Value Unit Total Volume 7.9 Milliliter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature -5 Degrees Celsius 50 Degrees Celsius Handling Environment Temperature 23 Degrees Fahrenheit 122 Degrees Fahrenheit Storage Environment Temperature -5 Degrees Celsius 50 Degrees Celsius Storage Environment Temperature 23 Degrees Fahrenheit 122 Degrees Fahrenheit
Regulatory Flags# DUNS number 790268031 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 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 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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