Home GUDID 04035479129569 Itrevia 7 VR-T
Primary DI 04035479129569
Brand Itrevia 7 VR-T
Company BIOTRONIK SE & Co. KG
Model 393041
Catalog number 393041
Published 2015-02-18
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 LWS Implantable cardioverter defibrillator (non-CRT)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04035479129569 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04035479129569 04035479129569 4035479129569
GMDN Terms# Term, Definition table Term Definition Single-chamber implantable defibrillator An implantable pulse generator with a cardiac rhythm recognition system, to analyse an electrocardiogram (ECG), that delivers an electrical impulse(s) to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate. It is implanted in a pouch beneath the skin of the patient's chest or abdomen and has connected leads that are positioned inside or on one heart chamber (typically a ventricle) to monitor the ECG and to automatically deliver the electrical impulse to treat ventricular fibrillation or tachycardia. The device has internal batteries that provide the energy to deliver the discharges; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD).
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 41 Degrees Fahrenheit 113 Degrees Fahrenheit
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 05414734500586 NA ST. JUDE MEDICAL, INC. LWS 2025-05-07 00763000180010 Sprint Quattro Secure S™ MEDTRONIC, INC. LWS 2024-11-04 00763000180058 Sprint Quattro Secure S MRI™ SureScan™ MEDTRONIC, INC. LWS 2024-11-04 00802526623400 NA BOSTON SCIENTIFIC CORPORATION LWS 2024-08-29 05415067049414 Entrant™ ST. JUDE MEDICAL, INC. LWS 2024-04-25 05415067049421 Gallant™ ST. JUDE MEDICAL, INC. LWS 2024-04-25 05415067049469 Entrant™ ST. JUDE MEDICAL, INC. LWS 2024-04-25 05415067049476 Gallant™ ST. JUDE MEDICAL, INC. LWS 2024-04-25 00763000369743 Epsila EV™ MEDTRONIC, INC. LWS 2023-11-03 00763000368470 Aurora EV-ICD™ MRI SureScan™ MEDTRONIC, INC. LWS 2023-11-02 00763000369767 Epsila EV™ MRI SureScan™ MEDTRONIC, INC. LWS 2023-11-02 00763000571528 NA MEDTRONIC, INC. LWS 2023-07-30 05415067037121 Merlin™ ST. JUDE MEDICAL, INC. LWS 2022-08-29 00802526615108 EMBLEM™ S-ICD Programmer BOSTON SCIENTIFIC CORPORATION LWS 2022-01-26 00802526588280 RESONATE™ HF ICD VR BOSTON SCIENTIFIC CORPORATION LWS 2021-07-12 00802526588310 RESONATE™ HF ICD DR BOSTON SCIENTIFIC CORPORATION LWS 2021-07-12 05415067032812 myMerlinPulse™ ST. JUDE MEDICAL, INC. LWS 2021-01-07 00763000178338 Cobalt™ XT DR MRI SureScan™ MEDTRONIC, INC. LWS 2020-11-22 00763000178345 Cobalt™ XT DR MRI SureScan™ MEDTRONIC, INC. LWS 2020-11-22 00763000178451 Cobalt™ XT VR MRI SureScan™ MEDTRONIC, INC. LWS 2020-11-22 00763000178468 Cobalt™ XT VR MRI SureScan™ MEDTRONIC, INC. LWS 2020-11-22 00643169720589 Evera MRI™ S VR SureScan® MEDTRONIC, INC. LWS 2020-11-13 00643169837751 Evera MRI™ XT VR SureScan™ MEDTRONIC, INC. LWS 2020-11-13 00763000060060 Visia AF MRI™ S VR SureScan™ MEDTRONIC, INC. LWS 2020-09-04 05415067031990 Gallant™ ST. JUDE MEDICAL, INC. LWS 2020-09-02 05415067032836 Entrant™ ST. JUDE MEDICAL, INC. LWS 2020-09-02 00763000178390 Cobalt™ DR MRI SureScan™ MEDTRONIC, INC. LWS 2020-06-08 00763000178499 Cobalt™ VR MRI SureScan™ MEDTRONIC, INC. LWS 2020-06-08 00802526611322 ZOOM® LATITUDE® BOSTON SCIENTIFIC CORPORATION LWS 2019-11-07 00802526610516 EMBLEM™ S-ICD Programmer BOSTON SCIENTIFIC CORPORATION LWS 2019-11-06
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