FDA.reportPublic FDA data

VYGON

Primary DI
00849884007824
Brand
VYGON
Company
Vygon Corporation
Model
AMS-9837CP-8
Catalog number
AMS-9837CP-8
Device description
PORT ACCESS KIT
Published
2026-09-25
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
OKEPort introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKEPort Introducer KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30849884007825PackageGS120In Commercial Distribution
00849884007824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084988400782530849884007825
00849884007824008498840078248498840078240849884007824

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheterization support/maintenance kit, non-medicatedA collection of non-dedicated devices intended for catheterization support and/or catheter maintenance (e.g., dressing change, catheter flushing) associated with peripheral venous, central venous, and/or arterial catheterization. Primarily intended to be used at the patient’s bedside, the kit includes devices such as: personal protective equipment (PPE), drapes, disinfectant wipes, dressings, needles, syringes, forceps, scissors, scalpel, tourniquets, ultrasound transducer cover, coupling gel, sharps container, and saline solution. Neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device.

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
00849884007589VYGONVYML4S3001NVYML4S3001N2026-06-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956578548CARDINAL HEALTHCardinal Health 200, LLCOKE2026-09-25
10198956539907CARDINAL HEALTHCardinal Health 200, LLCOKE2026-09-04
10198956569287CARDINAL HEALTHCardinal Health 200, LLCOKE2026-09-04
10198956572973CARDINAL HEALTHCardinal Health 200, LLCOKE2026-09-04
10198956552678CARDINAL HEALTHCardinal Health 200, LLCOKE2026-08-26
00199972000528CuraplexBOUND TREE MEDICAL, LLCOKE2026-08-15
10198956519633CARDINAL HEALTHCardinal Health 200, LLCOKE2026-07-27
10198956530409CARDINAL HEALTHCardinal Health 200, LLCOKE2026-07-27
10198956524644CARDINAL HEALTHCardinal Health 200, LLCOKE2026-07-20
10198956504141CARDINAL HEALTHCardinal Health 200, LLCOKE2026-07-09
10198956527980CARDINAL HEALTHCardinal Health 200, LLCOKE2026-07-09
10198956468474CARDINAL HEALTHCardinal Health 200, LLCOKE2026-06-23
10198956421448CARDINAL HEALTHCardinal Health 200, LLCOKE2026-06-08
10198956464070CARDINAL HEALTHCardinal Health 200, LLCOKE2026-06-05
10198956492936CARDINAL HEALTHCardinal Health 200, LLCOKE2026-06-05
10198956320161CARDINAL HEALTHCardinal Health 200, LLCOKE2026-06-01
10198956381469CARDINAL HEALTHCardinal Health 200, LLCOKE2026-06-01
10194717120162Regard™ROI CPS, LLCOKE2024-10-08
10194717120094Regard™ROI CPS, LLCOKE2024-10-02
10194717119807Regard™ROI CPS, LLCOKE2024-06-26
10194717119234Regard™ROI CPS, LLCOKE2024-04-12
10194717118336Regard™ROI CPS, LLCOKE2024-01-26
10194717117551Regard™ROI CPS, LLCOKE2023-06-21
10194717116660Regard™ROI CPS, LLCOKE2023-01-13
10195594396510CARDINAL HEALTHCardinal Health 200, LLCOKE2022-04-29
10194717115717Regard™ROI CPS, LLCOKE2022-04-14
10195594443092CARDINAL HEALTHCardinal Health 200, LLCOKE2022-02-26
10195594385910CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-28
10195594423025CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-28
10195594456214CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-28