VYGON

Basic Information

• Brand Name: VYGON
• Primary DI: 03660812129664
• Version / Model: 1272.14
• Catalog Number: 00127214
• Company Name: VYGON
• Labeler DUNS: 392994778
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-25
• Public Version: 1
• Public Version Date: 2023-08-02
• Public Version Status: New
• Public Device Record Key: 7257538e-c9bf-432c-a7a0-83224e9b02da

Device Description

Umbilical catheter - 4Fr - L.20cm - PUR (double lumen - 11ml/min / 12ml/min)

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	53660812129669	GS1		9	In Commercial Distribution
Package	33660812129665	GS1		10	In Commercial Distribution
Primary	03660812129664	GS1

Storage Conditions

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