FDA.report

VYGON

Primary DI
30849884002011
Brand
VYGON
Company
Vygon Corporation
Model
AMS-7200
Catalog number
AMS-7200
Device description
NEONATAL DRESSING CHANGE KIT
Published
2020-01-30
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

Related Records

Product Codes

CodeName
OXQDressing change tray

Product Code Classifications

CodeDeviceSpecialtyClass
OXQDressing Change TrayGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30849884002011PackageGS120In Commercial Distribution
00849884002010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3084988400201130849884002011
00849884002010008498840020108498840020100849884002010

GMDN Terms

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

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

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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
30849884007191VYGONAMS-2008AMS-20082025-09-24
30849884007221VYGONVYPL4D3003LRVYPL4D3003LR2025-09-23
30849884006941VYGONVYML3S3001SK-1VYML3S3001SK-12025-09-15
30849884006965VYGONVYPL3S3003SK-1VYPL3S3003SK-12025-09-15
30849884007009VYGONVYML5D3001SK-1VYML5D3001SK-12025-09-05
30849884006972VYGONVYPL4D3003SK-1VYPL4D3003SK-12025-08-29
30849884006989VYGONVYPL5T3003SK-1VYPL5T3003SK-12025-08-29
30849884007016VYGONVYPL4S3003SK-1VYPL4S3003SK-12025-08-29

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