Home GUDID 00868260000211 WavelinQ
Primary DI 00868260000211
Brand WavelinQ
Company TVA MEDICAL, INC.
Model FX-001CE
Catalog number FX-001CE
Device description WavelinQ™ 6F endoAVF System
Published 2018-08-27
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name PQK Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PQK Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00868260000211 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00868260000211 00868260000211 868260000211 0868260000211
GMDN Terms# Term, Definition table Term Definition Vascular guide-catheter, single-use A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 0 Device Size Text, specify 0 Device Size Text, specify 0
Regulatory Flags# DUNS number 018572046 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00199874301785 Ellipsys Medical Ellipsys, Inc. PQK 2026-06-03 00763000574710 Ellipsys Power Controller AVENU MEDICAL, INC. PQK 2021-12-10 00763000496975 Ellipsys Vascular Access System AVENU MEDICAL, INC. PQK 2021-02-08 00763000496982 Ellipsys Vascular Access System AVENU MEDICAL, INC. PQK 2021-02-08 00763000478193 Ellipsys Power Controller AVENU MEDICAL, INC. PQK 2021-01-27 00801741189104 WavelinQ CLEARSTREAM TECHNOLOGIES LIMITED PQK 2019-11-15 00801741182754 WavelinQ Bard Peripheral Vascular, Inc. PQK 2019-02-22 B357AMI1001 Ellipsys Power Controller AVENU MEDICAL, INC. PQK 2018-10-24 B357AMI6005 Ellipsys Vascular Access System AVENU MEDICAL, INC. PQK 2018-10-24 B357AMI1000 Ellipsys Power Controller AVENU MEDICAL, INC. PQK 2018-09-18 B357AMI6050 Ellipsys Vascular Access System AVENU MEDICAL, INC. PQK 2018-09-18
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