VYGON

Basic Information

• Brand Name: VYGON
• Primary DI: 03660812065900
• Version / Model: 368.1021
• Catalog Number: 368.1021
• Company Name: VYGON
• Labeler DUNS: 392994778
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 6
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: 31300bed-5e26-4602-8a49-2a7cc2e0fc12
• Distribution End Date: 2019-01-15

Device Description

Nutrisafe 2 extension tubes with clamp

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
FPD	TUBE, FEEDING	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62256	Enteral tube extension	A thin, flexible tube intended for extracorporeal connection to an enteral feeding tube (e.g., nasogastric tube) to increase the length of tubing from the patient to an oral/enteral device (e.g., syringe) during enteral feeding/medication administration or aspiration. It is typically a single-lumen, rubber or plastic tube of various diameters/lengths. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	53660812065905	GS1		6	Not in Commercial Distribution	2019-01-15
Package	33660812065901	GS1		50	Not in Commercial Distribution	2019-01-15
Primary	03660812065900	GS1

Storage Conditions

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