VYGON

Basic Information

• Brand Name: VYGON
• Primary DI: 08498840013151
• Version / Model: AMS-750
• Catalog Number: AMS-750
• Company Name: Vygon Corporation
• Labeler DUNS: 120818216
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-02
• Public Version: 1
• Public Version Date: 2019-08-12
• Public Version Status: New
• Public Device Record Key: d7485c51-637d-40fb-ba83-a66c79ff64e7

Device Description

SOLUTIONS ACCESSORY KIT

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OWL	Peripheral catheter insertion kit	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58865	Vascular catheter introduction set, nonimplantable	A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	38498840013152	GS1		20	In Commercial Distribution
Primary	08498840013151	GS1