FDA.reportPublic FDA data

VYGON

Primary DI
30849884004602
Brand
VYGON
Company
Vygon Corporation
Model
AMS-8502CP-2
Catalog number
AMS-8502CP-2
Device description
PICC DRESSING CHANGE KIT
Published
2020-04-28
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
30849884004602PackageGS120In Commercial Distribution
00849884004601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084988400460230849884004602
00849884004601008498840046018498840046010849884004601

GMDN Terms#

Term, Definition table
TermDefinition
Arterial/central venous catheterization support/maintenance kitA collection of sterile 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. It is primarily intended to be used at the patient’s bedside and includes devices intended to support catheter placement and/or or ongoing maintenance (e.g., dressing change, catheter flushing) such as: disposable drapes, disinfectant wipes, dressings, gown, tourniquets, ultrasound system transducer cover, coupling gel, sharps container, syringe, 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
00849884007619VYGONAMS-9869CSAMS-9869CS2026-08-31
00849884007718VYGONMS022MS0222026-10-19
00849884007770VYGONPIP100000TPIP100000T2026-10-09
08498840001691VYGONAMS-6180CPAMS-6180CP2016-08-09
08498840001707VYGONAMS-6186CPAMS-6186CP2016-08-09
08498840002148VYGONAMS-7192CS-2AMS-7192CS-22016-09-15
08498840002735VYGONAMS-8133AMS-81332016-09-07
08498840002889VYGONAMS-8180-3CPAMS-8180-3CP2016-09-07
08498840002902VYGONAMS-8181CPAMS-8181CP2016-09-07
08498840002940VYGONAMS-8198-1AMS-8198-12016-09-15
08498840002957VYGONAMS-8198CSAMS-8198CS2016-09-15
08498840002964VYGONAMS-8199AMS-81992016-09-15
08498840003213VYGONAMS-8280CP-4AMS-8280CP-42016-09-15
08498840003688VYGONAMS-8423CPAMS-8423CP2016-09-07
08498840004005VYGONAMS-8485CP-1AMS-8485CP-12016-09-15
08498840004333VYGONAMS-8712CP-1AMS-8712CP-12016-09-02
08498840004784VYGONAMS-9093CPAMS-9093CP2016-09-02
08498840004814VYGONAMS-9152CPAMS-9152CP2016-09-02
08498840004951VYGONAMS-923CPAMS-923CP2016-09-02
08498840005071VYGONAMS-9294AMS-92942016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10653160395461MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10653160395713MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10653160395720MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10653160395782MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10653160395805MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10653160395812MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10653160395911MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-24
10198956594739CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-23
10198956596276CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-23
10198956531666CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956565470CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956577374CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956588134CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956593749CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10198956593756CARDINAL HEALTHCardinal Health 200, LLCOXQ2026-10-15
10653160393894MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394310MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394426MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394433MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394457MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394556MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394587MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394662MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394679MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394693MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160394907MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395072MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395096MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395102MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15
10653160395218MEDLINEMEDLINE INDUSTRIES, INC.OXQ2026-10-15