VasQ

Basic Information

• Brand Name: VasQ
• Primary DI: 07290016063363
• Version / Model: 6
• Catalog Number: FG0036
• Company Name: LAMINATE MEDICAL TECHNOLOGIES LTD
• Labeler DUNS: 600196773
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-26
• Public Version: 2
• Public Version Date: 2024-02-28
• Public Version Status: Update
• Public Device Record Key: de72e670-292d-4258-8032-f9a3255c1d12

Device Description

External support for vascular access arteriovenous fistulas

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
QVQ	Extravascular Support For An Arteriovenous Fistula For Vascular Access	Cardiovascular	870.4600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62497	Arteriovenous fistula extraluminal mesh-sleeve	A non-bioabsorbable, implantable device intended to be used for the extraluminal (external) support of an arteriovenous fistula (AVF) to facilitate viable maturation and patency of the AVF for haemodialysis. It is a metal mesh structure intended to improve the characteristics of the AVF (e.g., luminal uniformity, flow capability, luminal strength/stability) to reduce the risk of failure from adverse events such as thrombosis, intimal hyperplasia, and stenosis.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016063363	GS1