VYGON

Basic Information

• Brand Name: VYGON
• Primary DI: 03660812124492
• Version / Model: 812.000
• Catalog Number: 000812000
• Company Name: VYGON-Erzeugnisse für Medizin und Chirurgie-GmbH und Co. KG
• Labeler DUNS: 315994731
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-09
• Public Version: 1
• Public Version Date: 2021-06-17
• Public Version Status: New
• Public Device Record Key: b8991b5d-07d2-4d14-9fb7-15472bd13501

Device Description

Extension set for ECC

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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LJS	Catheter, intravascular, therapeutic, long-term greater than 30 days	General Hospital	880.5970	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12170	Intravenous administration tubing extension set	A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	33660812124493	GS1	Box	25	In Commercial Distribution
Primary	03660812124492	GS1
Package	53660812124497	GS1	Case	8	In Commercial Distribution

Storage Conditions

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