FDA.reportPublic FDA data

VYGON

Primary DI
30849884003445
Brand
VYGON
Company
Vygon Corporation
Model
AMS-9335CP-2
Catalog number
AMS-9335CP-2
Device description
CVC TRAY PEDIATRICS
Published
2020-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
30849884003445PackageGS120In Commercial Distribution
00849884003444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084988400344530849884003445
00849884003444008498840034448498840034440849884003444

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
120818216
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
30849884007474VYGONAMS-7170CPAMS-7170CP2026-03-06
30849884007320VYGONAMS-8070CP AMS-8070CP 2026-02-11
30849884007313VYGONVYLFMM1004 VYLFMM1004 2026-01-23
50849884007300VYGONVYLFMM1003VYLFMM10032026-01-22
30849884007122VYGONVYPL5T1003-1 VYPL5T1003-1 2025-11-20
30849884007146VYGONVYPL4S1001LW-1VYPL4S1001LW-12025-11-20
30849884007030VYGONVYML3S1003-1 VYML3S1003-1 2025-09-26
30849884007078VYGONVYPL3S1003-1VYPL3S1003-12025-09-26
30849884007214VYGONAMS-9777CPAMS-9777CP2025-09-26
30849884007047VYGONVYML4D1003-1 VYML4D1003-1 2025-09-25
30849884007085VYGONVYPL4D1003-1 VYPL4D1003-1 2025-09-25
30849884007207VYGONAMS-2087CPAMS-2087CP2025-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956074123CARDINAL HEALTHCardinal Health 200, LLCOFK2025-06-26
50198956010770CARDINAL HEALTHCardinal Health 200, LLCOFK2025-04-25
50197106927944CARDINAL HEALTHCardinal Health 200, LLCOFK2025-03-20
00685447019466VersaCross Connect™ LAAC Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019473VersaCross Connect™ LAAC Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019480VersaCross Connect™ LAAC Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019497VersaCross Connect™ LAAC Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019503VersaCross Connect™ LAAC Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019558VersaCross™ Large Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019565VersaCross™ Large Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019572VersaCross™ Large Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019589VersaCross™ Large Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019596VersaCross™ Large Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019602VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019619VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019626VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019633VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019640VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019657VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019664VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019671VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019688VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019695VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019701VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019718VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019725VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019732VersaCross™ Steerable Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019749VersaCross™ Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019756VersaCross™ Access SolutionBaylis Médicale Cie IncOFK2025-02-25
00685447019763VersaCross™ Access SolutionBaylis Médicale Cie IncOFK2025-02-25