Nutrifit
Vygon USA
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1223004 | 1000120555 | Vygon MFG | 1 | N | 2026-01-01 | 87 Venture Dr DOVER NH US 03820 |
| 2245270 | 2245270 | VYGON USA | 1 | Y | 2026-01-01 | 2750 Morris Rd Suite A200 Lansdale PA US 19446 |
| 3011237770 | 3011237770 | Vygon Verneuil | 1 | N | 2026-01-01 | Parc Alata 5 Avenue des Bouleaux Verneuil En Halatte Oise FR 60550 |
| 3014663754 | 3014663754 | Vygon Portugal | 1 | N | 2026-01-01 | Parque Empresarial de Baltar/Parada Rua F 7585-013 Balter-Paredes Porto PT 7585-013 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 220307 | 1325727741 | K981630 | VYGON DOUBLE LUMEN UMBILICAL CATHETER | FOS | 1998-10-01 |
| 83215 | 1903883627 | K963981 | VYGON BIONECTOR WITH EXTENSION SET | FPA | 1997-02-14 |
| 220307 | 1430307758 | K963196 | VYGON UMBILICAL CATHETHER INSERTION TRAY | FOZ | 1997-09-09 |
| 36496 | 2037311133 | K963196 | VYGON UMBILICAL CATHETHER INSERTION TRAY | FOZ | 1997-09-09 |
| 36496 | 1577722295 | K954302 | VYGON PREMI-CATH - LONG TERM CATHETER | LJS | 1996-06-17 |
| 83215 | 1577722295 | K954302 | VYGON PREMI-CATH - LONG TERM CATHETER | LJS | 1996-06-17 |
| 220307 | 1717718718 | K925854 | VYGON - ENTERAL FEEDING TUBE - POLYURETHANE | KNT | 1994-05-02 |
| 220307 | 1432488089 | K921374 | VYGON XRO VENOUS/ARTERIAL UMBILICAL CATHETER | FOS | 1992-10-26 |
| 220307 | 1596272302 | K921352 | VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH | FOS | 1992-10-26 |
| 36496 | 1177594369 | K902482 | VITALMIX (SET & BAG) | LHI | 1990-07-02 |
| 83215 | 1177594369 | K902482 | VITALMIX (SET & BAG) | LHI | 1990-07-02 |
| 36496 | 2032504157 | K896333 | CMS IV FILTERS | FPB | 1990-01-11 |
| 83215 | 2032504157 | K896333 | CMS IV FILTERS | FPB | 1990-01-11 |
| 36496 | 1929710773 | K894954 | .22 & 1.2 MICRON IV FILTERS | FPB | 1989-11-13 |
| 83215 | 1929710773 | K894954 | .22 & 1.2 MICRON IV FILTERS | FPB | 1989-11-13 |
| 83215 | 1079995687 | K884370 | CMS IV EXTENSION SETS | FPK | 1988-11-07 |
| 36496 | 1706223075 | K882503 | 30 IV EXTENSION SET W/TWO MALE LUER LOCKS | FPA | 1988-08-25 |
| 83215 | 1706223075 | K882503 | 30 IV EXTENSION SET W/TWO MALE LUER LOCKS | FPA | 1988-08-25 |
| 36496 | 1206883023 | K873957 | NON-CORING HUBER TYPE NEEDLES | FMI | 1987-10-23 |
| 83215 | 1206883023 | K873957 | NON-CORING HUBER TYPE NEEDLES | FMI | 1987-10-23 |
| 220307 | 1274448326 | K851005 | XRO UMBILICAL CATHETER-CODE 270 | FOS | 1985-05-21 |
| 220307 | 1078243648 | K822879 | ENTERAL NUTRITION 1 | KNT | 1982-11-16 |
| 220307 | 1641327647 | K243361 | Nutrifit | FPD | 2024-12-19 |
| 36496 | 1436071345 | K212370 | Leaderflex Mini and Leaderflex Nano | FOZ | 2022-08-29 |
| 83215 | 1436071345 | K212370 | Leaderflex Mini and Leaderflex Nano | FOZ | 2022-08-29 |
| 36496 | 1935866264 | K210047 | Stiletto Extended Dwell Catheter | PND | 2021-08-27 |
| 36496 | 1400711621 | K181208 | Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter | PND | 2018-11-02 |
| 83215 | 1400711621 | K181208 | Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter | PND | 2018-11-02 |
| 36496 | 1473195786 | K172899 | Vygon PICCs | LJS | 2018-02-26 |
| 83215 | 1473195786 | K172899 | Vygon PICCs | LJS | 2018-02-26 |
| 36496 | 1428486809 | K153533 | Tearaway Introducer Sheath, MicroSlide Tearaway Introducer | DYB | 2016-07-05 |
| 83215 | 1428486809 | K153533 | Tearaway Introducer Sheath, MicroSlide Tearaway Introducer | DYB | 2016-07-05 |
| 36496 | 1066182931 | K141026 | LEADERFLEX | FOZ | 2014-07-30 |
| 83215 | 1066182931 | K141026 | LEADERFLEX | FOZ | 2014-07-30 |
| 36496 | 1973407761 | K122834 | POLYSITE IMPLANTABLE INFUSION PORTS | LJT | 2013-12-11 |
| 83215 | 1973407761 | K122834 | POLYSITE IMPLANTABLE INFUSION PORTS | LJT | 2013-12-11 |
| 36496 | 1499095673 | K101368 | D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES | FPA | 2010-11-18 |
| 220307 | 1919533320 | K100163 | NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX | FPD | 2011-10-13 |
| 36496 | 1581420357 | K082580 | SPECTRA GUIDEWIRE INTRODUCER NEEDLE | DYB | 2008-12-08 |
| 83215 | 1581420357 | K082580 | SPECTRA GUIDEWIRE INTRODUCER NEEDLE | DYB | 2008-12-08 |
| 36496 | 1628240378 | K070705 | MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039 | FOZ | 2007-11-30 |
| 83215 | 1628240378 | K070705 | MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039 | FOZ | 2007-11-30 |
| 36496 | 1246226938 | K063631 | POLYPERF / POLYPERF SAFE | FPA | 2007-10-05 |
| 36496 | 1157631453 | K062425 | LIFECATH S PICC AND MIDLINE CATHETER | LJS | 2006-09-15 |
| 83215 | 1157631453 | K062425 | LIFECATH S PICC AND MIDLINE CATHETER | LJS | 2006-09-15 |
| 220307 | 1278045899 | K060944 | NUTRISAFE 2 | FPD | 2006-09-15 |
| 36496 | 1868006499 | K060944 | NUTRISAFE 2 | FPD | 2006-09-15 |
| 83215 | 1868006499 | K060944 | NUTRISAFE 2 | FPD | 2006-09-15 |
| 36496 | 1336099723 | K053049 | ALARIS SAFETY MALE LUER | FPA | 2006-01-12 |
| 83215 | 1336099723 | K053049 | ALARIS SAFETY MALE LUER | FPA | 2006-01-12 |
| 36496 | 1612860544 | K052881 | VYGON LATEX FREE BIONECTOR | FOZ | 2006-03-02 |
| 36496 | 1287779773 | K052475 | VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS | LJS | 2006-09-14 |
| 83215 | 1287779773 | K052475 | VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS | LJS | 2006-09-14 |
| 36496 | 1570555402 | K051690 | VYGON NUTRILINE CATHETERS | LJS | 2005-08-19 |
| 83215 | 1570555402 | K051690 | VYGON NUTRILINE CATHETERS | LJS | 2005-08-19 |
| 36496 | 1575531662 | K041468 | PREMICATH, 1261.205 | LJS | 2004-09-09 |
| 83215 | 1575531662 | K041468 | PREMICATH, 1261.205 | LJS | 2004-09-09 |
| 83215 | 1219458690 | K041038 | CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER | KPE | 2004-12-21 |
| 36496 | 2035063565 | K031923 | ULTRASITE VALVE | FPA | 2003-08-11 |
| 83215 | 2035063565 | K031923 | ULTRASITE VALVE | FPA | 2003-08-11 |
| 36496 | 1409469268 | K030135 | SAFETY INTRODUCER NEEDLE | DYB | 2003-07-15 |
| 83215 | 1409469268 | K030135 | SAFETY INTRODUCER NEEDLE | DYB | 2003-07-15 |
| 36496 | 1496873710 | K021990 | GALT MEDICAL GUIDEWIRE | DQX | 2002-07-18 |
| 83215 | 1496873710 | K021990 | GALT MEDICAL GUIDEWIRE | DQX | 2002-07-18 |
| 36496 | 1029025386 | K021395 | MODIFICATION TO 30 EXTENSION SET | FPA | 2002-05-13 |
| 83215 | 1029025386 | K021395 | MODIFICATION TO 30 EXTENSION SET | FPA | 2002-05-13 |
| 36496 | 1202621180 | K020544 | WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA | FPA | 2002-03-12 |
| 83215 | 1202621180 | K020544 | WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA | FPA | 2002-03-12 |
| 36496 | 1975301856 | K013950 | VENTED VIAL ACCESS DEVICE | FPA | 2002-01-10 |
| 83215 | 1975301856 | K013950 | VENTED VIAL ACCESS DEVICE | FPA | 2002-01-10 |
| 36496 | 1665828510 | K013949 | UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR | FPA | 2002-03-27 |
| 83215 | 1665828510 | K013949 | UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR | FPA | 2002-03-27 |
| 36496 | 1317575625 | K013884 | BOUSSIGNAC C.P.A.P. DEVICE | BYE | 2003-01-21 |
| 83215 | 1317575625 | K013884 | BOUSSIGNAC C.P.A.P. DEVICE | BYE | 2003-01-21 |
| 220310 | 1435191617 | K013884 | BOUSSIGNAC C.P.A.P. DEVICE | BYE | 2003-01-21 |
| 36496 | 1884463835 | K013871 | LIFEGUARD SAFETY INFUSION SET | FPA | 2002-03-29 |
| 83215 | 1884463835 | K013871 | LIFEGUARD SAFETY INFUSION SET | FPA | 2002-03-29 |
| 36496 | 1669909898 | K012157 | CHURCHILL MEDICAL SYSTEMS STOPCOCK | FMG | 2001-09-11 |
| 83215 | 1669909898 | K012157 | CHURCHILL MEDICAL SYSTEMS STOPCOCK | FMG | 2001-09-11 |
| 36496 | 1568858933 | K011888 | PRESSURE ACTIVATED CHECK VALVE | FPA | 2001-09-10 |
| 83215 | 1568858933 | K011888 | PRESSURE ACTIVATED CHECK VALVE | FPA | 2001-09-10 |
| 36496 | 1899706451 | K011336 | PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK | FPA | 2001-06-12 |
| 83215 | 1899706451 | K011336 | PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK | FPA | 2001-06-12 |
| 83215 | 1029469488 | K010913 | VYGON SPLIT CANNULA INTRODUCER | DYB | 2001-09-28 |
| 220310 | 1006610622 | ||||
| 36496 | 1022057925 | ||||
| 83215 | 1022057925 | ||||
| 220310 | 1030435187 | ||||
| 36496 | 1037188799 | ||||
| 83215 | 1037188799 | ||||
| 220310 | 1073653784 | ||||
| 36496 | 1074160994 | ||||
| 83215 | 1074160994 | ||||
| 220310 | 1078243648 | ||||
| 36496 | 1079995687 | ||||
| 220310 | 1086028499 | ||||
| 220310 | 1093816621 | ||||
| 220310 | 1104729377 | ||||
| 83215 | 1109918483 | ||||
| 220310 | 1130666438 | ||||
| 220310 | 1134734486 | ||||
| 220310 | 1144806147 | ||||
| 83215 | 1175971994 | ||||
| 220310 | 1209933652 | ||||
| 83215 | 1215403011 | ||||
| 36496 | 1239140145 | ||||
| 83215 | 1239140145 | ||||
| 83215 | 1246226938 | ||||
| 220310 | 1258302097 | ||||
| 220310 | 1262750805 | ||||
| 220310 | 1271233991 | ||||
| 220310 | 1274448326 | ||||
| 220310 | 1278045899 | ||||
| 220310 | 1294375698 | ||||
| 220310 | 1304594744 | ||||
| 220310 | 1307319623 | ||||
| 220310 | 1315990829 | ||||
| 220310 | 1316010521 | ||||
| 220310 | 1325727741 | ||||
| 220310 | 1327289455 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FPA | 23 | 2010-11-18 |
| LJS | 12 | 2018-02-26 |
| FOZ | 9 | 2022-08-29 |
| DYB | 7 | 2016-07-05 |
| FPD | 5 | 2024-12-19 |
| FOS | 4 | 1998-10-01 |
| FPB | 4 | 1990-01-11 |
| PND | 3 | 2021-08-27 |
| BYE | 3 | 2003-01-21 |
| LJT | 2 | 2013-12-11 |
| DQX | 2 | 2002-07-18 |
| FMG | 2 | 2001-09-11 |
| KNT | 2 | 1994-05-02 |
| LHI | 2 | 1990-07-02 |
| FMI | 2 | 1987-10-23 |
| KPE | 1 | 2004-12-21 |
| FPK | 1 | 1988-11-07 |
Vygon USA
Vygon USA
Vygon USA
Vygon USA
VYGON
VYGON
VYGON CORP.
VYGON CORP.
VYGON NEURO
VYGON CORP.
VYGON CORP.
VYGON CORP.
VYGON CORP.
VYGON CORP.
VYGON CORP.
VYGON US LLC
VYGON CORP.
VYGON CORP.
VYGON CORP.
VYGON CORP.
VYGON S A
VYGON US LLC
VYGON S A
VYGON CORP.
VYGON CORP.
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