FDA Registration
Active
🇨🇴 Colombia
VYGON COLOMBIA S.A.
Reg #: 3004569180
·
FEI: 3004569180
·
Expires 2026
Products
8
Proprietary Names
34
Establishment Types
3
Classifications
8
Registration Details
- Registration Name
- VYGON COLOMBIA S.A.
- Registration Number
- 3004569180
- FEI Number
- 3004569180
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- CALLE 79 NO 75-342 L2
- City
- BARRANQUILLA Atlantico
- Country
- CO
Regulatory Submissions
- 510(k) Number
- K910909
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 |
| Tube, Tracheal (W/Wo Connector) | BTR | Class 2 | Anesthesiology | No | 2012-03-26 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2006-11-21 |
| Filter, Infusion Line | FPB | Class 2 | General Hospital | No | 2019-02-04 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2014-09-15 |
| Tubing, Fluid Delivery | FPK | Class 2 | General Hospital | No | 2014-09-15 |
| Tube, Feeding | FPD | Class 2 | Gastroenterology, Urology | No | 2015-08-31 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2010-01-13 |
Proprietary Names
Mucaid
Vygon Double Lumen Endotracheal Tube
IMPREGNATED SURGICAL BRUSH
Filter Administration Sets
Intravascular Extension Set
AMS-899-G
SSP-395
AMS-435CV-1
SS-761B
AMS-391
AMS-635CV-1
516.XX
80.516.3XX
520.XX
VYGON ENDOTRACHEAL TUBE
Filter Set
AMS-924C-1
AMS-467
AMS-467C
246X2
MICROFLEX
Nutrisafe 2
IV Administration Set
AMS-975NF
KS-975NF-2
AMS-105-1
AMS-184-1
AMS-975-1
AMS-975NF-2
KS-222-2
AMS-122-1
0000-9752-01
Intravascular Extension Sets
Sponge stick
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Sterilize Medical Device for Another Party (Contract Sterilizer)