FDA.reportPublic FDA data

VYGON

Primary DI
08498840009741
Brand
VYGON
Company
Vygon Corporation
Model
AMS-7100CS-1
Catalog number
AMS-7100CS-1
Device description
CENTRAL LINE MAINTENANCE KIT
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OFKPercutaneous atrial catheter kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFKPercutaneous Atrial Catheter KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38498840009742PackageGS120In Commercial Distribution
08498840009741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3849884000974238498840009742
08498840009741084988400097418498840009741

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Regulatory Flags#

DUNS number
120818216
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849884007435VYGON2015SPI2015SPI2026-05-22
00849884007442VYGON2015SPIMST2015SPIMST2026-05-22
00849884007459VYGON3015SPI3015SPI2026-05-22
00849884007466VYGON3015SPIMST3015SPIMST2026-05-22
00849884007510VYGONVYML4S3001A-1VYML4S3001A-12026-05-22
00849884007527VYGONVYML5D3003AVYML5D3003A2026-05-22
00849884007541VYGONVIS-1045VIS-10452026-05-22
00849884007558VYGONVIS-1055VIS-10552026-05-22
00849884007350VYGON3017PI3017PI2026-05-01
00849884007374VYGON4018PI4018PI2026-05-01
00849884007398VYGONPIP200000PIP2000002026-05-01
00849884007497VYGONAMS-599AMS-5992026-04-24
00849884007480VYGONVY-MAXPROVY-MAXPRO2026-04-09
00849884007336VYGON2016PI2016PI2026-03-31
00849884007343VYGON2016SPI2016SPI2026-03-31
00849884007367VYGON3017SPI3017SPI2026-03-31
00849884007381VYGON4018SPI4018SPI2026-03-31
00849884007473VYGONAMS-7170CPAMS-7170CP2026-03-06
30849884007474VYGONAMS-7170CPAMS-7170CP2026-03-06
00849884007404VYGONPIP200100PIP2001002026-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956399396CARDINAL HEALTHCardinal Health 200, LLCOFK2026-04-27
10198956353244CARDINAL HEALTHCardinal Health 200, LLCOFK2026-04-09
10198956335189CARDINAL HEALTHCardinal Health 200, LLCOFK2026-02-12
10198956202665CARDINAL HEALTHCardinal Health 200, LLCOFK2025-10-20
10198956074125CARDINAL HEALTHCardinal Health 200, LLCOFK2025-06-26
50198956074123CARDINAL HEALTHCardinal Health 200, LLCOFK2025-06-26
10198956010772CARDINAL HEALTHCardinal Health 200, LLCOFK2025-04-25
50198956010770CARDINAL HEALTHCardinal Health 200, LLCOFK2025-04-25
10197106927946CARDINAL HEALTHCardinal Health 200, LLCOFK2025-03-20
50197106927944CARDINAL HEALTHCardinal Health 200, LLCOFK2025-03-20
00685447019466VersaCross Connect™ LAAC Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019473VersaCross Connect™ LAAC Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019480VersaCross Connect™ LAAC Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019497VersaCross Connect™ LAAC Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019503VersaCross Connect™ LAAC Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019558VersaCross™ Large Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019565VersaCross™ Large Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019572VersaCross™ Large Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019589VersaCross™ Large Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019596VersaCross™ Large Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019602VersaCross™ Steerable Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019619VersaCross™ Steerable Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019626VersaCross™ Steerable Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019633VersaCross™ Steerable Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019640VersaCross™ Steerable Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019657VersaCross™ Steerable Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019664VersaCross™ Steerable Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019671VersaCross™ Steerable Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019688VersaCross™ Steerable Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25
00685447019695VersaCross™ Steerable Access SolutionBOSTON SCIENTIFIC CORPORATIONOFK2025-02-25