FDA.reportPublic FDA data

VYGON

Primary DI
30849884003605
Brand
VYGON
Company
Vygon Corporation
Model
AMS-9837CP-7
Catalog number
AMS-9837CP-7
Device description
PORT ACCESS KIT
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
OKEPort introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKEPort Introducer KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30849884003605PackageGS120In Commercial Distribution
00849884003604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084988400360530849884003605
00849884003604008498840036048498840036040849884003604

GMDN Terms#

Term, Definition table
TermDefinition
Arterial/central venous catheterization support/maintenance kit, non-medicatedA collection of devices intended to support the catheterization procedure of an artery and/or central vein (large veins of the upper body), and/or to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). 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, 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.

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
50198956293159CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-23
50198956420708CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-23
50198956424478CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-23
50198956412321CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-19
50198956328134CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-10
50198956322194CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-03
50198956339741CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-03
50198956363531CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-03
50198956401011CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-03
50198956375688CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-02
50198956377095CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-02
50198956398625CARDINAL HEALTHCardinal Health 200, LLCOKE2026-03-02
50198956336023CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-23
50198956359060CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-23
50198956359770CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-23
50198956380446CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-23
50198956323030CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-20
50198956333992CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-20
50198956344530CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-20
50198956338096CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-17
50198956323115CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-13
50198956322682CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-09
50198956333626CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-09
50198956335200CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-02
50198956356243CARDINAL HEALTHCardinal Health 200, LLCOKE2026-02-02
50198956341591CARDINAL HEALTHCardinal Health 200, LLCOKE2026-01-30
50198956306118CARDINAL HEALTHCardinal Health 200, LLCOKE2026-01-23
50198956258585CARDINAL HEALTHCardinal Health 200, LLCOKE2026-01-22
00191072241610ACSAMERICAN CONTRACT SYSTEMS, INC.OKE2026-01-14
00191072241634ACSAMERICAN CONTRACT SYSTEMS, INC.OKE2026-01-14