VWING Vascular Needle Guide

Basic Information

• Brand Name: VWING Vascular Needle Guide
• Primary DI: 08199260101496
• Version / Model: 00149
• Catalog Number: 00149
• Company Name: VITAL ACCESS CORPORATION
• Labeler DUNS: 180346285
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-02-04
• Public Version: 4
• Public Version Date: 2022-06-17
• Public Version Status: Update
• Public Device Record Key: 96788257-b5ab-4eff-8996-b7ecc211763c

Device Description

VWING Vascular Needle Guide 10mm x 9mm

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: MR Conditional
• 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
PFH	Venous Window Needle Guide	Gastroenterology, Urology	876.5540	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58816	Arteriovenous fistula buttonhole cannulation guide	A metal implant intended to be attached (sutured) to, or placed above, an arteriovenous fistula (AVF) under the skin to act as a guide when using a constant site (buttonhole) method of blunt needle insertion. It is typically used during haemodialysis procedures where the device can be palpated (felt) beneath the skin and the cannulation directed into the device where it will funnel the needle point towards a constant entry site in the vessel wall. It is typically made of titanium (Ti) and is available in a range of sizes.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08199260101496	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	18	Millimeter
Width	9	Millimeter
Height	10	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry. Keep away from heat. Store in a dry place at room temperature.