VYGON

Basic Information

• Brand Name: VYGON
• Primary DI: 03660812128773
• Version / Model: 270.04
• Catalog Number: 00027004
• Company Name: VYGON
• Labeler DUNS: 392994778
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-09
• Public Version: 1
• Public Version Date: 2022-06-17
• Public Version Status: New
• Public Device Record Key: 532084a3-8f73-42da-9310-5abb47e727f2

Device Description

Umbilical catheter - 4Fr - L.37cm - 16ml/min - PVC

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
FOS	CATHETER, UMBILICAL ARTERY	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10759	Umbilical catheter	A very thin flexible tube designed for umbilical blood vessel access in neonates, typically for the infusion of fluids. It is used mainly in arterial catheterization procedures, but venous catheterization is also possible. It will typically have a double or triple lumen to enable additional concurrent functions such as vital sign monitoring and blood sampling (e.g., for blood gas analysis). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	33660812128774	GS1	Box	15	In Commercial Distribution
Primary	03660812128773	GS1
Package	53660812128778	GS1	Case	15	In Commercial Distribution

Storage Conditions

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