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Катетеры для радиологии с принадлежностями для катетеризации (см. Приложение на 11 листах)

ФС № 2005/583

Параметры изделия

Уникальный номер реестровой записи
53134
Статус
Внесено изменение
Регистрационный номер медицинского изделия
ФС № 2005/583
Дата государственной регистрации медицинского изделия
2005-04-20
Срок действия регистрационного удостоверения
2015-02-25
Наименование медицинского изделия
Катетеры для радиологии с принадлежностями для катетеризации (см. Приложение на 11 листах). I. 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 
 BARDSeIect Range, Standard, Fixed Core, 3 Tip, Stainless Steel, PTFE Coated 
 BARDSe1ect Range, Standard, Fixed Core, Straight, Stainless Steel, PTFE Coated 
 BARDSeIect 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 призводства 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 
Наименование организации-заявителя
ООО "Гаммамед-ИМПЕКС"
Производитель медицинского изделия
C.R. Bard GmbH (заводы: Bard Peripheral Vascular, Inc., США; Bard Access Systems, США)
Адрес производителя
ФРГ, Мексика, Пуэрто-Рико

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