VYGON

Basic Information

• Brand Name: VYGON
• Primary DI: 08498840005262
• Version / Model: AMS-949
• Catalog Number: AMS-949
• Company Name: Vygon Corporation
• Labeler DUNS: 120818216
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-09
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: e5fe0f26-a1e3-467a-967c-10e3d8beda70

Device Description

0.2 MICRON SUPOR GARDIAN FILTER 25mm FLL/MLL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• 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
FPB	Filter, infusion line	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35072	Intravenous line filter	A sterile device designed to remove microorganisms and particulate matter from solutions in an infusion/intravenous (IV) line; it can also be used to remove air. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	38498840005263	GS1		50	In Commercial Distribution
Primary	08498840005262	GS1