FDA Registration
Active
🇫🇷 France
Vygon Verneuil
Reg #: 3011237770
·
FEI: 3011237770
·
Expires 2026
Products
36
Proprietary Names
133
Establishment Types
2
Classifications
36
Registration Details
- Registration Name
- Vygon Verneuil
- Registration Number
- 3011237770
- FEI Number
- 3011237770
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Parc Alata, 5 Avenue des Bouleaux
- City
- Verneuil En Halatte Oise
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K013884
Owner / Operator
- Firm Name
- VYGON S A
- Operator Number
- 8020785
- Address
- 5-11 RUE ADELINE, --
- City
- ECOUEN
- State
- FR-NOTA
- Postal Code
- 95440
- Country
- FR
- Correspondent
- Chris Steinke
US Agent
- Business Name
- Vygon USA
- Contact Name
- Chris Steinke
- Address
- 87 Venture Drive
- City
- Dover
- State
- NH
- ZIP
- 03820
- Country
- US
- [email protected]
- Phone
- 603 7435988 ext. 227
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2008-02-02 |
| Cannula, A-V Shunt | FIQ | Class 2 | Gastroenterology, Urology | No | 2016-07-20 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2012-03-26 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2016-07-20 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2012-01-13 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2012-03-26 |
| Tubing, Fluid Delivery | FPK | Class 2 | General Hospital | No | 2014-09-15 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2008-02-02 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2015-08-31 |
| Port & Catheter, Implanted, Subcutaneous, Intravascular | LJT | Class 2 | General Hospital | No | 2018-06-19 |
| Port Introducer Kit | OKE | Class 2 | General Hospital | No | 2018-06-19 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2015-08-31 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2018-06-19 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2018-06-19 |
| Cannula, Catheter | DQR | Class 2 | Cardiovascular | No | 2014-01-24 |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2008-02-02 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2015-02-26 |
| Tube, Feeding | FPD | Class 2 | Gastroenterology, Urology | No | 2025-01-14 |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | Class 2 | Anesthesiology | No | 2005-10-05 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2013-03-12 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2016-05-13 |
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2007-08-06 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2015-06-10 |
| Enteral Specific Transition Connectors | PIO | Class 2 | Gastroenterology, Urology | No | 2016-07-20 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2015-01-08 |
| Catheter, Umbilical Artery | FOS | Class 2 | General Hospital | No | 2012-03-26 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2006-11-21 |
| Regulator, Pressure, Gas Cylinder | CAN | Class 1 | Anesthesiology | No | 2014-08-18 |
| Set, Blood Transfusion | BRZ | Class 2 | General Hospital | No | 2015-01-08 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2008-02-02 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2013-06-28 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2007-08-06 |
| Strap, Head, Gas Mask | BTK | Class 1 | Anesthesiology | No | 2005-11-29 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2012-03-26 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2015-08-31 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2010-01-13 |
Proprietary Names
Mucaid
Hemoclav
PVC Enteral Feeding Tubes
Desilet
Vygon Split Cannula Introducer
Dermafilm
Vygon Double Lumen Endotracheal Tube
Intravascular Extension Set
AMS-924C-1
AMS-467
AMS-467C
PUR Umbilical Catheter
Thoracic trocar and drain
Polysite
Boussignac
Nutrisafe 2
PPS PI
Delee
Lifevac
Intraflon 2
122
121
Premicath
Silicone Enteral Feeding Tubes
Bionector
Lifecath
XRO Gastro-Duodenal Dual Flow Salem Type Feeding Tube
Multicath Expert
Double Taper Connector
Nutrisafe
Multicath
Nutrifit Enteral Feeding Tube - Closed tip-PUR-1366.Xxx
368.xxxx
1362.xxx
1364.xxx
362.xxx
363.xxx
361.xxx
1363.xxx
1361.xxx
368.xxx
366.xxx
364.xxx
1366.xxx
Nutrifit Enteral Feeding Tube-PVC 366.Xxx
BOUSSIGNAC C.P.A.P. DEVICE
Lectrocath
Caps and Connectors
PUR Epicutaneo-Cave Catheter
Nasal Oxygen Catheter
Leaderflex
BOUGIE BOUSSIGNAC T
Grip-Lok
Twinflo
Nutriline
Vygon NeoSump Gastric Aspirator
Nutrisafe 2 - ENFit Adaptor
NeoHelp
81757
1362
1364
1361
361
364
8187
817.207
82887
1363
817572
NUTRIFIT SAMPLING STRAW
339172
NUTRIFIT
36897
368.47
82817
362
363
817.208
368.1572
817.157
58027
Vygon XRO PVC Venous/Arterial Umbilical Catheter
IMPREGNATED SURGICAL BRUSH
FiO2 Adaptor Ring
Vygon Exchange Transfusion Tray
275.xxx
Polyperf
Leader-Cath
Vygon PVC XRO Venous/Arterial Umbilical Catheter
Epicutaneo-Cava Catheter
Vygon Spinal Anesthesia Needle w/ Introducer
Vygon PUR Enteral Feeding Tubes
Vygocard 2
916402
9168.202
TRACHEOBRONCHIAL
CATHETERS
BOUGIE BOUSSIGNAC
Vygon Multi-Dose Vial Adaptor and Bionector
246X2
MICROFLEX
Lectospiral
FIXATION HARNESS FOR FACIAL MASK
Vyclic
Leader-flex
1362871
1362.1271
1362.1671
1366671
1362.1072
1366.1871
1362671
1362.1272
1362.1471
1366871
1366.1271
1366872
1366.1072
1362.1871
1366.1272
1362872
1366.1471
1362.1071
1366.1671
Sponge stick
Vygon PVC Umbilical Catheter
AMS-899-G
SSP-395
AMS-435CV-1
SS-761B
AMS-391
AMS-635CV-1
Latex-Free Bionector
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Reprocess Single-Use Device