Home GUDID 04035479131968 Eluna 8 SR
Primary DI 04035479131968
Brand Eluna 8 SR
Company BIOTRONIK SE & Co. KG
Model 394972
Catalog number 394972
Published 2014-12-09
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name NVZ Pulse generator, permanent, implantable
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NVZ Pulse Generator, Permanent, Implantable Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04035479131968 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04035479131968 04035479131968 4035479131968
GMDN Terms# Term, Definition table Term Definition Single-chamber implantable pacemaker, rate-responsive A 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.
Storage And Handling# Type, Low, High table Type Low High Condition 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 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 00763000812058 NA MEDTRONIC, INC. NVZ 2025-04-12 05415067034809 Merlin@home™ ST. JUDE MEDICAL, INC. NVZ 2024-11-13 00763000378356 Instrument Command Library MEDTRONIC, INC. NVZ 2024-05-04 00763000378363 Device Command Library MEDTRONIC, INC. NVZ 2024-05-04 04035479173937 Solvia Rise SR-T BIOTRONIK SE & Co. KG NVZ 2023-07-12 04035479173944 Solvia Rise DR-T BIOTRONIK SE & Co. KG NVZ 2023-07-12 04035479173982 Amvia Edge SR-T BIOTRONIK SE & Co. KG NVZ 2023-07-12 04035479173999 Amvia Edge DR-T BIOTRONIK SE & Co. KG NVZ 2023-07-12 04035479174019 Amvia Sky SR-T BIOTRONIK SE & Co. KG NVZ 2023-07-12 04035479174026 Amvia Sky DR-T BIOTRONIK SE & Co. KG NVZ 2023-07-12 00763000612658 MyCareLink™ MEDTRONIC, INC. NVZ 2023-05-13 00763000612665 MyCareLink™ MEDTRONIC, INC. NVZ 2023-05-13 00763000688400 CareLink SmartSync™ MEDTRONIC, INC. NVZ 2022-10-28 00763000688479 NA MEDTRONIC, INC. NVZ 2022-10-28 00763000181321 NA MEDTRONIC, INC. NVZ 2021-06-12 00763000181345 NA MEDTRONIC, INC. NVZ 2021-06-12 00763000316709 Azure™ XT SR MRI SureScan™ MEDTRONIC, INC. NVZ 2021-02-25 00763000414023 MyCareLink™ MEDTRONIC, INC. NVZ 2021-02-07 00763000414030 MyCareLink™ MEDTRONIC, INC. NVZ 2021-02-07 00763000414047 MyCareLink™ MEDTRONIC, INC. NVZ 2021-02-07 00763000316693 Azure™ S DR MRI SureScan™ MEDTRONIC, INC. NVZ 2021-01-08 00763000316716 Azure™ S SR MRI SureScan™ MEDTRONIC, INC. NVZ 2021-01-08 00763000316846 Azure™ XT DR MRI SureScan™ MEDTRONIC, INC. NVZ 2021-01-08 00763000316723 Adapta™ MEDTRONIC, INC. NVZ 2020-11-28 00763000316730 Adapta™ MEDTRONIC, INC. NVZ 2020-11-28 00763000316747 Adapta™ S MEDTRONIC, INC. NVZ 2020-11-28 00763000316761 Adapta™ MEDTRONIC, INC. NVZ 2020-11-28 00763000316778 Adapta™ MEDTRONIC, INC. NVZ 2020-11-28 00763000316785 Adapta™ MEDTRONIC, INC. NVZ 2020-11-28 00763000316792 Adapta™ MEDTRONIC, INC. NVZ 2020-11-28
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