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
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 sterile, 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), 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 of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, is not a microcatheter (i.e., not intended to access superselective small vessels), and does not include a transseptal needle. It may include a disposable percutaneous introduction set. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 6 French Device Size Text, specify 0 Device Size Text, specify 0
Regulatory Flags# DUNS number 018572046 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 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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