FDA.report

VYGON

Primary DI
38498840010366
Brand
VYGON
Company
Vygon Corporation
Model
AMS-7480CS
Catalog number
AMS-7480CS
Device description
PORT ACCESS KIT
Published
2017-03-22
Public version status
Update
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
OKEPort introducer kit

Product Code Classifications

CodeDeviceSpecialtyClass
OKEPort Introducer KitGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
38498840010366PackageGS120In Commercial Distribution
08498840010365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3849884001036638498840010366
08498840010365084988400103658498840010365

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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