HIGH PRESSURE TUBING

Basic Information

• Brand Name: HIGH PRESSURE TUBING
• Primary DI: 00850004162118
• Version / Model: VGPMT0509
• Catalog Number: VGPMT0509
• Company Name: VALFLUX GROUP, LLC
• Labeler DUNS: 050193715
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-18
• Public Version: 1
• Public Version Date: 2019-01-18
• Public Version Status: New
• Public Device Record Key: da7406e6-2390-4791-891d-8b9b061f7ba0

Device Description

VGPMT0509 HIGH PRESSURE TUBING (180cm)

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: No
• 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
DXT	INJECTOR AND SYRINGE, ANGIOGRAPHIC	Cardiovascular	870.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10689	Arterial blood pressure catheter	A sterile, thin flexible tube intended for short-term (<= 30 days) percutaneous placement within an artery for continuous blood pressure monitoring. It is typically interfaced with a parent device (e.g., external blood pressure transducer) and may be used for arterial blood sampling. The catheter is flushed between sampling procedures; it is not intended to be used for the administration of medication or fluids. Devices dedicated to catheter introduction/function (e.g., introducer needle, guidewire, adaptor) may be included. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850004162118	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K170014	000