FDA.reportPublic FDA data

VYGON

Primary DI
08498840010273
Brand
VYGON
Company
Vygon Corporation
Model
AMS-9837CP-6
Catalog number
AMS-9837CP-6
Device description
PORT ACCESS KIT
Published
2016-09-20
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
OKEPort introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKEPort Introducer KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38498840010274PackageGS120In Commercial Distribution
08498840010273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3849884001027438498840010274
08498840010273084988400102738498840010273

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
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
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
10195594519599CARDINAL HEALTHCardinal Health 200, LLCOKE2022-04-21
10194717115717Regard™ROI CPS, LLCOKE2022-04-14
10195594443092CARDINAL HEALTHCardinal Health 200, LLCOKE2022-02-26
10195594463663CARDINAL HEALTHCardinal Health 200, LLCOKE2022-02-18
10195594510978CARDINAL HEALTHCardinal Health 200, LLCOKE2022-02-07
10195594530761CARDINAL HEALTHCardinal Health 200, LLCOKE2022-02-01
10195594385910CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-28
10195594423025CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-28
10195594456214CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-28
10195594508517CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-25
10195594530501CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-25
10195594518288CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-23
10194717114437Regard™ROI CPS, LLCOKE2022-01-13
10195594429225CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-13
10195594485108CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-13
10195594499464CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-07
10195594486945CARDINAL HEALTHCardinal Health 200, LLCOKE2022-01-04
10195594285456CARDINAL HEALTHCardinal Health 200, LLCOKE2021-12-30
10195594496050CARDINAL HEALTHCardinal Health 200, LLCOKE2021-12-30
10195594504755CARDINAL HEALTHCardinal Health 200, LLCOKE2021-12-28
10195594434274CARDINAL HEALTHCardinal Health 200, LLCOKE2021-12-22
10195594493004CARDINAL HEALTHCardinal Health 200, LLCOKE2021-12-22