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    Катетеры для радиологии с принадлежностями для катетеризацииI. Катетеры производства Bard

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    Параметр изделия

    Значение параметра

    Регистрационный номер

    РЗН 2015/2425

    Дата государственной регистрации

    25.02.2015

    Срок действия регистрационного удостоверения

    Наименование медицинского изделия

    Катетеры для радиологии с принадлежностями для катетеризацииI. Катетеры производства Bard Peripheral Vascular, Inc.: - Opti-Plast XT-Xtra-thin PTA Catheters - Lowest Profile Performance. - Opti-Plast XL-Xtra-large PTA Catheters - Lowest Profile Performance. - Opti-Plast PTA Catheters. - Ultraverse PTA Catheters - Premium Nylon Platform. - Bard Tru-Trac PTA Catheters. - PAC Balloon Dilatation Catheters. - CENTURION Balloon Dilatation Catheters. - CONQUEST Balloon Dilatation Catheters. II. Катетеры производства Angiomed GmbH & Co. Medizintechnik KG: - Angiomed Angiography Catheters, ANGIOFLEX, Non Braided Shaft, Cobra Version. - Angiomed Angiography Catheters, ANGIOFLEX, Non Braided Shaft, Divers Version. - Angiomed Angiography Catheters, ANGIOFLEX, Non Braided Shaft, Headhunter Version. - Angiomed Angiography Catheters, ANGIOFLEX, Non Braided Shaft, Hepatica Communis Version. - Angiomed Angiography Catheters, ANGIOFLEX, Non Braided Shaft, Hook Version. - Angiomed Angiography Catheters, ANGIOFLEX, Non Braided Shaft, Judkins Version. - Angiomed Angiography Catheters, ANGIOFLEX, Non Braided Shaft, Newton Version. - Angiomed Angiography Catheters, ANGIOFLEX, Non Braided Shaft, Pigtail Version. - Angiomed Angiography Catheters, ANGIOFLEX, Non Braided Shaft, Renal Version. - Angiomed Angiography Catheters, ANGIOFLEX, Non Braided Shaft, Shepered Hook Version. - Angiomed Angiography Catheters, ANGIOFLEX, Non Braided Shaft, Simmons Sidewinder Version. - Angiomed Angiography Catheters, ANGIOFLEX, Non Braided Shaft, Straight Version. - Angiomed Angiography Catheters, ANGIOPASS PLUS, Braided Shaft, Soft Tip, Hepatica Communis Version. - Angiomed Angiography Catheters, ANGIOPASS PLUS, Braided Shaft, Soft Tip, Shephered Hook Version Angiomed. - Angiography Catheters, ANGIOPASS PLUS, Braided Shaft, Soft Tip, Straight Version. - Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Cobra Version. - Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Divers Version. - Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Headhunter Version. - Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Judkins Version. - Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Multipurpose Version. - Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Pigtail Version. - Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Simmons Sidewinder Version. - Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Soft Tip, Cobra Version. - Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Soft Tip, Divers Version. - Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Soft Tip, Headhunter Version. - Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Soft Tip, Judkins Version. - Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Soft Tip, Multipurpose Version. - Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Soft Tip, Pigtail Version. - Angiomed Angiography Catheters, ANGIOPASS, Braided Shaft, Soft Tip, Simmons Sidewinder Version. - Angiomed Angiography Catheters, HIGH FLOW, Non Braided Shaft, Cobra Version. - Angiomed Angiography Catheters, HIGH FLOW, Non Braided Shaft, Divers Version. - Angiomed Angiography Catheters, HIGH FLOW, Non Braided Shaft, Hook Version. - Angiomed Angiography Catheters, HIGH FLOW, Non Braided Shaft, Pigtail Version. - Angiomed Angiography Catheters, HIGH FLOW, Non Braided Shaft, Radiopaque, Pigtail Version. - Angiomed Angiography Catheters, HIGH FLOW, Non Braided Shaft, Radiopaque, Straight Version. - Angiomed Angiography Catheters, HIGH FLOW, Non Braided Shaft, Renal Version. - Angiomed Angiography Catheters, HIGH FLOW, Non Braided Shaft, Simmons Sidewinder Version. - Angiomed Angiography Catheters, HIGH FLOW, Non Braided Shaft, Straight Version. - Angiomed Angiography Catheters, MAXI SELECT, Non Braided Shaft, Bentson Hanafee Wilson Version. - Angiomed Angiography Catheters, MAXI SELECT, Non Braided Shaft, Cobra Version. - Angiomed Angiography Catheters, MAXI SELECT, Non Braided Shaft, Divers Version. - Angiomed Angiography Catheters, MAXI SELECT, Non Braided Shaft, Headhunter Version. - Angiomed Angiography Catheters, MAXI SELECT, Non Braided Shaft, Hook Version. - Angiomed Angiography Catheters, MAXI SELECT, Non Braided Shaft, Mani Version. - Angiomed Angiography Catheters, MAXI SELECT, Non Braided Shaft, Pigtail Version. Angiomed Angiography Catheters, MAXI SELECT, Non Braided Shaft, Renal Version. - Angiomed Angiography Catheters, MAXI SELECT, Non Braided Shaft, Sheperd Hook Version. - Angiomed Angiography Catheters, MAXI SELECT, Non Braided Shaft, Simmons Sidewinder Version. - Angiomed Angiography Catheters, MAXI SELECT, Non Braided Shaft, Straight Version. - Angiomed Angiography Catheters, MAXI SELECT, Non Braided Shaft, Vertebralis Version. - Dacryography Catheter. - Galactography Catheter. - Mamillary Dilator. - Sialography Catheter. - PAT RAT, Aspiration Catheter, 1 Lumen. III Катетеры производства Bard Access Systems: - Broviac catheters. - Leonard catheters. - Hickman catheters. - Hohn catheters. - Groshong catheters. - Groshong PICC's. - Groshong midline catheters. - Per-Q-Cath P1CC. - Per-Q-Cath Midline catheters. - RadPICC catheters. - ChronoFlex catheters Hickman Hemodialysis catheters. - Soft-Cell catheters Opti-Flow catheters. - Hemo-Glide catheters. - Hemo-Split catheters. - Flexxicon I and II catheters. - Niagara catheters. - Trialysis catheters. - Vaccess Femoral catheters. - Vaccess Subclavian jugular catheters. - Vaccess jugular catheters. - Arterial catheters DuPen Long term epidural catheters. - AngioCath intravenous catheters. IV.Принадлежности для катетеризации: 1. Проводники производства Angiomed GmbH & Co. Medizintechnik KG: - Amplatz, Moveable Core, J Tip, Stainless Steel,PTFE Coated. - Amplatz, Moveable Core, Straight, Stainless Steel, PTFE Coated. - BARDSe1ect Range, Amplatz, Moveable Core, J Tip, Stainless Steel, PTFE Coated. - BARDSe1ect Range, Amplatz, Moveable Core, Straight, Stainless Steel, PTFE Coated. - BARDSe1ect Range, Standard, Fixed Core, Double Ended, J Tip, Stainless Steel, PTFE Coated. - BARDSe1ect, Standard, Fixed Core, 3 Tip, Stainless Steel, PTFE Coated. - BARDSe1ect Range, Standard, Fixed Core, Straight, Stainless Steel, PTFE Coated. - BARDSelect Range, Standard, Moveable Core, J Tip, Stainless Steel, PTFE Coated. - BARDSe1ect Range, Standard, Moveable Core, Straight, Stainless Steel, PTFE Coated. - Bentson, Fixed Core, Straight, Stainless Steel, PTFE Coated. - Heavy Duty, Fixed Core, Straight, Stainless Steel, PTFE Coated. - Interventional Guide Wire, Fixed Core, Angled, Nitinol. - Interventional Guide Wire, Fixed Core, J Tip, Nitinol. - Interventional Guide Wire, Fixed Core, Straight, Nitinol. - Portacaval Guiding Probe, Fixed Core, Straight, Nitinol. - Soft Torque, WHITE WIRE, Fixed Core, Straight, Nitinol, PTFE Coated. - Standard, Fixed Core, Double Ended, J Tip, Stainless Steel. - Standard, Fixed Core, Double Ended, J Tip, Stainless Steel, PTFE Coated. - Standard, Fixed Core, J Tip, Stainless Steel. - Standard, Fixed Core, J Tip, Stainless Steel, PTFE Coated. - Standard, Fixed Core, Straight, Stainless Steel. - Standard, Fixed Core, Straight, Stainless Steel, PTFE Coated. - Standard, Moveable Core, J Tip, Stainless Steel. - Standard, Moveable Core, J Tip, Stainless Steel, PTFE Coated. - Standard, Moveable Core, Straight, Stainless Steel. - Standard, Moveable Core, Straight, Stainless Steel, PTFE Coated. - Torque, BARDSe1ect Range, BLUE WIRE, Fixed Core, Angled, Nitinol, PTFE Coated. - Ultra Torque, BARD Se1ect Range, BLACK WIRE, Fixed Core, Angled, Nitinol, FEP Coated.- Ultra Torque, BARD Se1ect Range, BLACK WIRE, Fixed Core, Straight, Nitinol, FEP. Coated. - Ultra Torque, BARD SeIect Range, BLUE WIRE, Fixed Core, Straight, Nitinol, PTFE Coated. - Ultra Torque, BLACK WIRE, Angled, Nitinol, FEP Coated. - Ultra Torque, BLACK WIRE, Fixed Core, Straight, Nitinol, FEP Coated. Soft Torque, WHITE WIRE,Fixed Core, Angled, Nitinol, PTFE Coated. - Torque, BLUE WIRE, Fixed Core, Angled, Nitinol, PTFE Coated. - Torque, BLUE WIRE, Fixed Core, Straight, Nitinol, PTFE Coated. - Guide Wires for Duodenal Stents (I). - Litholapaxy Wires, J Curved. - Litholapaxy Wires, J Curved, PTFE Coated. - Litholapaxy Wires, Straight Version,PTFE Coated. - Litholapaxy Wires, Straight Version PTC Guide Wires acc. to LUNDERQUIST. - Safety Wires, Interventional, Straight Version. - SCHULLER Exchange Wires, J Curved. - SCHULLER Exchange Wires, J Curved, PTFE Coated. - SCHULLER Exchange Wires, Straight Version. - SCHULLER Exchange Wires, Straight Version, PTFE Coated. - SCHULLER Litholapaxy Wires, Double Ended. - SCHULLER Litholapaxy Wires, J Curved. - SCHULLER Litholapaxy Wires, J Curved, PTFE Coated. - SCHULLER Exchange Wires, J Curved, PTFE Coated. - SCHULLER Exchange Wires, Straight Version. - SCHULLER Exchange Wires, Straight Version, PTFE Coated. - SCHULLER Litholapaxy Wires, Double Ended. - SCHULLER Litholapaxy Wires, J Curved. - SCHULLER Litholapaxy Wires, J Curved, PTFE Coated. - Special Exchange Wires, J Curved. - Special Exchange Wires, J Curved, PTFE Coated. - Special Exchange Wires, PTFE Coated Accessories Guide Wires, Pin Vise. 2. Проводники производства Bard Access Systems: - Guidewires. 3. Иглы производства Angiomed GmbH & Co. Medizintechnik KG: - Angiography Needles. - Arterial Puncture Needle BARDSeIect Range, Standard Cut. - Arterial Puncture Needle Standard Cut. - BARDSe1ect Range, Percutaneouse Entry Needle, Standard Cut. - CHIBA Needle Bevel Edged, 2 Part. - CHIBA Needle Bevel Edged, 2 Part, Graduated. - CHIBA Needle MS Cut, 2 Part. - CHIBA Needle MS Cut, 2 Part, Graduated. - Discography Set acc. to DR ZUBER. - Initial Puncture Needle Trocar Cut, 3 Part. - Initial Puncture Needle, Bevel Edged, 2 Part, Graduated, Model LORETTO. - Initial Puncture Needle, Bevel Edged, 2 Part, Model LORETTO. - Initial Puncture Needle, Bevel Edged, 2 Part, Model MERHEIM. - Initial Puncture Needle, Bevel Edged, 2 Part, Model OLDENBURG. - Initial Puncture Needle, Bevel Edged, 3 Part. - Initial Puncture Needle, MS Cut, 1 Part. - Initial Puncture Needle, MS Cut, 2 Part. - Initial Puncture Needle, MS Cut, 3 Part. - Initial Puncture Needle, MS Cut, 3 Part, Graduated. - Needle, Collagene Injection Needle, Bevel Edged, 1Part. - Needle, Hepatom Needle, Type I. - Needle, Hepatom Needle, Type II. - Percutaneouse Entry Needle modified acc. to Jantsch. - Percutaneouse Entry Needle, BARDSe1ect Range modified acc. to Jantsch. - Percutaneouse Entry Needle, Standard Cut. - Puncture Needle SUPER 4 modified ace. to Jantsch. - Puncture Needle SUPER 4, BARDSe1ect Range modified acc. to Jantsch. - Puncture Set acc. to STACKL. - SUPER 4 Needle, Arterial Puncture Needle. - SUPER 4 Needle, Puncture Needle, BARDSelect Range. - Initial Needle Set, 2 Part, PTFE Catheter. - Initial Puncture Needle, 2 Part, PTFE Catheter. - LEIGEN Needle Set, 2 Part, PTFE Catheter. - PTC initial Needle Set, 1 Part, PE Catheter. - Puncture Needle, 1 Part, PTFE Catheter. - SENGE Needle, 1 Part, High Flow Catheter. - Tumor Marking Set, Hook Wire. 4. Иглы производства Bard Access Systems: - Hustead needles. - Winged infusion sets with non-coring needle. - Non-coring needles. - Hypodermic needles. 5.Интродюсеры производства Angiomed GmbH & Co. Medizintechnik KG: - Introducer Set with Haemostatic Valve. - Introducer Set with Puncture Needle, Class IIa. - Percutaneous Introducer Set, Version A, Class IIa. - Percutaneous Introducer Set, Version B, Class IIa. - Special Introducer Set. - PAT RAT Introducer System, acc to STARCK. 6. Интродюсеры производства Bard Access Systems: - Seldinger technique type introducers: Peel apart, Co-axial design. - Sheath over-the-needle type introducers. - Peel-apart micro introducers and excalibur introducers, Co-axial design (IV catheter). - Over the guidewire type vessel dilators. 7. Принадлежности для ремонта катетеров производства Bard Access Systems: - External catheter segments for Broviac and Hickman CV catheters. - External catheter segments for Hickman and Leonard CV catheters.- Hickman CV repair kit - extension legs. - Groshong CV catheter repair kits for single lumen catheters. - Groshong CV catheter repair kits for multi lumen catheters. - Groshong CV catheter repair kit - extension legs. - Per-Q-Cath P1CC repair connectors. - DuPen epidural catheter repair kits. 8. Порты производства Bard Access Systems: - M.R.I. Low profile infusion ports. - M.R.I. Implanted ports (plastic or titanium stem). - M.R.I. Hard base implanted ports. - M.R.I. Dual implanted ports (plastic or titanium). - Titanium Low profile implanted ports (Slim Port). - Titanium Dome implanted ports. - Titanium implanted ports. - SlimPort Rosenblatt dual low profile implanted ports. - SlimPort ultra low profile M.R.I ports with titanium stem. - X-Port low profile implanted ports. - X-Port isp implanted ports. - CathLink Standard Profile (SP) ports. - CathLink Low Profile (LP) ports. - CathLink Ultra-Low Profile (ULP) ports. 9. Шунты производства Angiomed GmbH & Co. Medizintechnik KG: - Transjugular Intrahepatic Stent Shunt (TIPSS) Products, Porta Caval Set - Transjugular Intrahepatic Stent Shunt (TIPSS) Products, Porta Caval Guide Catheter, HIGHFLOW. - Transjugular Intrahepatic Stent Shunt (TIPSS) Products, Porta Caval Guide Catheter, PTFE. - Transjugular Intrahepatic Stent Shunt (TIPSS) Products, Porta Caval Introducer Set. - Transjugular Intrahepatic Stent Shunt (TIPSS) Products, Porta Caval Needle. 10. Коннекторы производства Angiomed GmbH & Co. Medizintechnik KG: - Contrast Media Connector, BARDSelect Range, Male and Female Luer Lock, Type B. - Contrast Media Connector, BARDSelect Range, Male/Female Luer Lock, Type A. - Contrast Media Connector, Male/Female Luer Lock, Type A. - Contrast Media Connector, Male/Female Luer Lock, Type B. - HIGH FLEX Connector, BARDSelect Range, Male to Female Luer Lock, Type A. - HIGH FLEX Connector, BARDSelect Range, Type B. - HIGH FLEX Connector, Male to Female Luer Lock, Type A. - HIGH FLEX Connector, Male to Female Luer Lock, Type B. - Pressure Connector, BARDSelect Range, Male to Female Luer Lock. - Pressure Connector, BARDSelect Range, Male to Female Lur Lock. - Pressure Connector, Male and Female Luer Lock, Typ B. - Pressure Connector, Male Luer Lock to Two Way Stopcock. - Pressure Connector, Male to Female Luer Lock, Typ A. 11. Адаптеры производства Angiomed GmbH & Co. Medizintechnik KG: - Connecting Adapter, Female Luer Lock. - Connecting Adapter, Male Luer Lock. - Tuhey Borst Adapter. 12. Краники производства Angiomed GmbH & Co. Medizintechnik KG: - 2 Way Stopcock, Female Luer Lock. - 3 Way Stopcock, 2 Female Luer Lock. 13. Емкости производства Angiomed GmbH & Co. Medizintechnik KG: - Section Bag without Bacteria Filter. - Urine Bag with Bacteria Filter. - Urine Bag without Bacteria Filter. - Urine Leg Bag without Bacteria Filter. 14. Расщепляющая оболочка интродюсера производства Angiomed GmbH & Co. Medizintechnik KG: - Accessories Introducer Split Sheath. 15. Гемостатический клапан для катетеров производства Angiomed GmbH & Co. Medizintechnik KG: - Haemostatic Valve for Catheters, Diameter from 4-9F. - Haemostatic Valve for Catheters, Diameter from 5-8F. 16. Тромбоэкстраторы производства Angiomed GmbH & Co. Medizintechnik KG: - RAT Fragmentation Basket ace. to STARCK. - RAT Fragmentation Basket with Flexible Tip ace. to STARCK. 17. Дренажи производства Angiomed GmbH & Co. Medizintechnik KG: - Pericard Drainage Sets (Class III). 18. Фильтры производства Bard Peripheral Vascular, Inc.: - Simon Nitinol Filter. 19. Фильтры производства Bard Access Systems: - 0.22 Micron filter for use with epidural catheter. 20. Инфляторы производства Bard Peripheral Vascular, Inc.: - Max 30 Inflation Device. - Max 30i Inflation Device. 21. Стилеты производства Bard Access Systems: - Coated stylets Uncoated stylets Threader stylets. 22. Коннекторы производства Bard Access Systems: - Groshong Replacement Connectors. 23. Скальпели производства Bard Access Systems: - Scalpels. 24. Туннелеры производства Bard Access Systems: - Tunnelers. 25. Расширительные сеты производства Bard Access Systems: - Extension sets. 26. Зажимы производства Bard Access Systems: - Clamps. 27. Инъекционные насадки производства Bard Access Systems: - Injection caps. 28. Ножницы производства Bard Access Systems: - Scissors. 29. Отделители вен производства Bard Access Systems: - Vein picks. 30. Иглодержатели производства Bard Access Systems: - Needle holders. 31. Щприц-инжектор производства Bard Access Systems: - Syringes Flushing hubs. 32. Зажимы производства Bard Access Systems: - Forceps.Место производства:1. Bard Peripheral Vascular, Inc.,

    Наименование организации – заявителя

    ООО "Бард Рус"

    Место нахождения организации-заявителя

    121596, Россия, г. Москва, ул. Горбунова, д. 2, стр. 204

    Юридический адрес организации-заявителя

    121596, Россия, г. Москва, ул. Горбунова, д. 2, стр. 204

    Наименование организации-производителя или организации-изготовителя

    "Бард Эксесс Системс, Инк."

    Место нахождения организации-производителя или организации – изготовителя

    , США, Дальнее зарубежье, Bard Access Systems, Inc., 605 North 5600 West, Salt Lake City, Utah, 84116, USA

    Юридический адрес организации-производителя или организации – изготовителя

    , США, Дальнее зарубежье, Bard Access Systems, Inc., 605 North 5600 West, Salt Lake City, Utah, 84116, USA

    ОКП/ОКПД2

    94 3600

    Класс потенциального риска применения медицинского изделия

    2б

    Назначение медицинского изделия, установленное производителем

    Адрес места производства или изготовления медицинского изделия

    1. Bard Peripheral Vascular, Inc., 1625 West 3 Street, Tempe, AZ, 85281 USA,2. Bard Access Systems, Inc., 605 North 5600 West Salt Lake City, Utah, 84116 USA3. Bard Reynosa S.A. De C.V. Blvd., Montebello Nol Parque Industrial Colonial Reynosa, Tamaulipas, Mexico4. Angiomed GmbH & Co. Medizintechnik KG, Wachhausstrasse 6, 76227 Karlsruhe, Germany

    Контакты производителя медицинского изделия

    Контакты дистрибутора в России №1

    Контакты дистрибутора в России №2

    Контакты дистрибутора в России №3

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