FDA.reportPublic FDA data

VYGON

Primary DI
30849884003209
Brand
VYGON
Company
Vygon Corporation
Model
AMS-8405CP-3
Catalog number
AMS-8405CP-3
Device description
DRESSING CHANGE 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
OXQDressing change tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXQDressing Change TrayGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30849884003209PackageGS120In Commercial Distribution
00849884003208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084988400320930849884003209
00849884003208008498840032088498840032080849884003208

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
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
10193489111224MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-08-04
10193489190106MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-01-01
10193489190113MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-01-01
10193489190120MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-01-01
10193489190151MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-01-01
10193489190397MEDLINEMEDLINE INDUSTRIES, INC.OXQ2022-01-01
10193489112689MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-11-01
10193489112528MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25
10193489112597MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25
10193489112603MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25
10193489112610MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25
10193489112627MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25
10193489112641MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25
10193489112658MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-25
10193489112184MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-18
10193489112191MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-18
10193489112207MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-18
10193489112214MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-18
10193489112221MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-18
10193489112238MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-18
10193489112115MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-11
10193489112122MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-11
10193489112139MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-11
10193489112146MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-11
10193489112177MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-10-11
10193489111798MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-09-24
10193489111804MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-09-24
10193489111729MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-09-17
10193489111767MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-09-17
10193489111705MEDLINEMEDLINE INDUSTRIES, INC.OXQ2021-09-09