WavelinQ FX-001CE

GUDID 00868260000211

WavelinQ™ 6F endoAVF System

TVA MEDICAL, INC.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use

• Primary Device ID: 00868260000211
• NIH Device Record Key: f77ab0a8-15ca-46bf-8fe5-273f82354e2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WavelinQ
• Version Model Number: FX-001CE
• Catalog Number: FX-001CE
• Company DUNS: 018572046
• Company Name: TVA MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com
• Phone: +1(512)582-2460
• Email: medical.services@crbard.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Gauge: 6 French
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868260000211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN160006

FDA Product Code

• PQK: Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-01-23
• Device Publish Date: 2018-08-27

Devices Manufactured by TVA MEDICAL, INC.

• 00868260000211 - WavelinQ: 2019-01-23WavelinQ™ 6F endoAVF System
• 00868260000211 - WavelinQ: 2019-01-23 WavelinQ™ 6F endoAVF System
• 00868260000228 - Electrosurgical Generator: 2018-09-20 Electrosurgical Generator