Home GUDID 00801741182754 WavelinQ
Primary DI 00801741182754
Brand WavelinQ
Company Bard Peripheral Vascular, Inc.
Model W04200
Catalog number W04200
Device description WavelinQ™ 4F EndoAVF System
Published 2019-02-22
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 00801741182754 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 00801741182754 00801741182754 801741182754 0801741182754
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 135057938 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 true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00801741000331 UltraClip® II Breast Tissue Marker 861017 861017 2015-09-25 00801741032004 SenoMark® Ultra Breast Tissue Marker SMEC7C SMEC7C 2015-10-02 00801741032011 SenoMark® Ultra Breast Tissue Marker SMEC7R SMEC7R 2015-10-02 00801741032028 SenoMark® Ultra Breast Tissue Marker SMEC10C SMEC10C 2015-10-01 00801741032035 SenoMark® Ultra Breast Tissue Marker SMEC10R SMEC10R 2015-10-01 00801741032042 SenoMark® Ultra Breast Tissue Marker SMEC12C SMEC12C 2015-10-01 00801741032059 SenoMark® Ultra Breast Tissue Marker SMEC12R SMEC12R 2015-10-02 00801741032066 SenoMark® Ultra Breast Tissue Marker SMMA11C SMMA11C 2015-10-01 00801741032073 SenoMark® Ultra Breast Tissue Marker SMMA11R SMMA11R 2015-10-01 00801741032080 SenoMark® Ultra Breast Tissue Marker SMAT9C SMAT9C 2015-10-02 00801741032097 SenoMark® Ultra Breast Tissue Marker SMAT9R SMAT9R 2015-10-02 00801741032103 SenoMark® Ultra Breast Tissue Marker SMAT12C SMAT12C 2015-10-01 00801741032110 SenoMark® Ultra Breast Tissue Marker SMAT12R SMAT12R 2015-10-01 00801741032127 SenoMark® Ultra Breast Tissue Marker SMEV9C SMEV9C 2015-10-02 00801741032134 SenoMark® Ultra Breast Tissue Marker SMEV9R SMEV9R 2015-10-02 00801741032219 UltraClip® Dual Trigger Breast Tissue Marker 862017D 862017D 2015-09-25 00801741032226 UltraClip® Dual Trigger Breast Tissue Marker 862017DL 862017DL 2015-09-25 00801741032233 UltraClip® Dual Trigger Breast Tissue Marker 863017D 863017D 2015-09-25 00801741032240 UltraClip® Dual Trigger Breast Tissue Marker 863017DL 863017DL 2015-09-25 00801741032257 UltraClip® Dual Trigger Breast Tissue Marker 864017D 864017D 2015-09-25
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 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 00868260000211 WavelinQ TVA MEDICAL, INC. PQK 2018-08-27
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