Home GUDID 05414734502610 Quickflex™
Primary DI 05414734502610
Brand Quickflex™
Company ST. JUDE MEDICAL, INC.
Model µ
Catalog number 1258T-86
Device description Left Heart Lead
Published 2017-04-10
Public version status Update
Distribution status 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 OJX Drug eluting permanent left ventricular (lv) pacemaker electrode
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OJX Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05414734502610 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05414734502610 05414734502610 5414734502610
GMDN Terms# Term, Definition table Term Definition Endocardial pacing lead A sterile, implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pulse generator to the heart; it is not intended to conduct defibrillation impulses. It may also transmit electrical responses from the heart back to the pacemaker. The electrode end is normally placed through a vein to contact the wall of one of the heart's chambers (endocardium), and the other end is connected to the pacemaker. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 5 French Length 86 Centimeter
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 Special Storage Condition, Specify 0 0 Storage excursions permitted from 15-30°C (59-86°F). For Trans/Handling excursions allowed from -5-50°C (23-122°F) Keep dry, Keep away from sunlight, Protect from heat and radioactive sources Special Storage Condition, Specify 0 0 Storage excursions permitted from 59°- 86° F (15°- 30°C). Storage Environment Temperature -5 Degrees Celsius 50 Degrees Celsius Storage Environment Temperature 20 Degrees Celsius 25 Degrees Celsius Storage Environment Temperature 23 Degrees Fahrenheit 122 Degrees Fahrenheit Storage Environment Temperature 68 Degrees Fahrenheit 77 Degrees Fahrenheit
Regulatory Flags# DUNS number 790268031 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product true 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 04035479138400 Sentus BIOTRONIK SE & Co. KG OJX 2019-07-15 04035479138417 Sentus BIOTRONIK SE & Co. KG OJX 2019-07-15 04035479138424 Sentus BIOTRONIK SE & Co. KG OJX 2019-07-15 04035479138431 Sentus BIOTRONIK SE & Co. KG OJX 2019-07-15 04035479138448 Sentus BIOTRONIK SE & Co. KG OJX 2019-07-15 04035479138455 Sentus BIOTRONIK SE & Co. KG OJX 2019-07-15 04035479145613 Sentus BIOTRONIK SE & Co. KG OJX 2019-07-15 04035479148966 Sentus BIOTRONIK SE & Co. KG OJX 2019-07-15 00643169860414 Attain Stability™ Quad MRI SureScan™ MEDTRONIC, INC. OJX 2019-05-26 00643169860421 Attain Stability™ Quad MRI SureScan™ MEDTRONIC, INC. OJX 2019-05-26 04035479145590 Sentus BIOTRONIK SE & Co. KG OJX 2017-05-18 04035479145606 Sentus BIOTRONIK SE & Co. KG OJX 2017-05-18 04035479148942 Sentus BIOTRONIK SE & Co. KG OJX 2017-05-18 04035479148959 Sentus BIOTRONIK SE & Co. KG OJX 2017-05-18 05414734502603 Quickflex™ ST. JUDE MEDICAL, INC. OJX 2017-04-10 05414734502627 Quickflex™ ST. JUDE MEDICAL, INC. OJX 2017-04-10 05414734506823 SJM™ ST. JUDE MEDICAL, INC. OJX 2017-04-10 05414734510172 Quartet™ ST. JUDE MEDICAL, INC. OJX 2017-03-30 05414734510189 Quartet™ ST. JUDE MEDICAL, INC. OJX 2017-03-30 00643169860025 Attain Ability™ MRI SureScan™ MEDTRONIC, INC. OJX 2017-03-24 00643169860124 Attain Ability™ Plus MRI SureScan™ MEDTRONIC, INC. OJX 2017-03-24 00643169860131 Attain Ability™ Plus MRI SureScan™ MEDTRONIC, INC. OJX 2017-03-24 00643169601789 Attain Ability™ Plus MRI SureScan™ MEDTRONIC, INC. OJX 2016-02-26 00643169601857 Attain Performa™ Straight MRI SureScan™ MEDTRONIC, INC. OJX 2016-02-26 00643169601864 Attain Performa™ S MRI SureScan™ MEDTRONIC, INC. OJX 2016-02-26 00643169590588 ATTAIN® BIPOLAR OTW MEDTRONIC, INC. OJX 2016-01-14 00643169590632 ATTAIN STARFIX™ MEDTRONIC, INC. OJX 2016-01-14 00643169590649 ATTAIN STARFIX™ MEDTRONIC, INC. OJX 2016-01-14 00643169590656 ATTAIN STARFIX™ MEDTRONIC, INC. OJX 2016-01-14 00643169002487 ATTAIN® PERFORMA™ STRAIGHT MEDTRONIC, INC. OJX 2014-12-16
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