VYGON

Basic Information

• Brand Name: VYGON
• Primary DI: 03660812003018
• Version / Model: 246.09
• Catalog Number: 246.09
• Company Name: VYGON
• Labeler DUNS: 392994778
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 4
• Public Version Date: 2018-10-22
• Public Version Status: Update
• Public Device Record Key: 2d3a7f21-c644-47d6-a033-ee69d8df8a3b

Device Description

Microflex

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPA	Set, administration, intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35211	Scalp vein needle	A very slender, sterile, sharp bevel-edged, hollow tubular metal instrument designed for use on the veins of the scalp or other small veins, especially in paediatric patients. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	53660812003013	GS1		40	In Commercial Distribution
Package	33660812003019	GS1		20	In Commercial Distribution
Primary	03660812003018	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius