Home GUDID 00801741189104 WavelinQ
Primary DI 00801741189104
Brand WavelinQ
Company CLEARSTREAM TECHNOLOGIES LIMITED
Model WQ4300
Catalog number WQ4300
Device description WavelinQ™ EndoAVF System
Published 2019-11-15
Public version status Update
Distribution status 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 00801741189104 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 00801741189104 00801741189104 801741189104 0801741189104
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 989214291 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 00801741129698 Halo One™ Thin-Walled Guiding Sheath HAL510F HAL510F 2016-06-10 00801741184802 Halo One™ Thin-Walled Guiding Sheath HLO41018FH HLO41018FH 2020-04-27 00801741184819 Halo One™ Thin-Walled Guiding Sheath HLO41035FH HLO41035FH 2020-04-27 00801741184833 Halo One™ Thin-Walled Guiding Sheath HLO51018FH HLO51018FH 2020-04-27 00801741184840 Halo One™ Thin-Walled Guiding Sheath HLO51035FH HLO51035FH 2020-04-27 00801741184864 Halo One™ Thin-Walled Guiding Sheath HLO61035FH HLO61035FH 2020-04-27 00801741219139 Halo One Thin-Walled Guiding Sheath HLO61018FH HLO61018FH 2021-11-15 00801741223778 Halo One Thin-Walled Guiding Sheath HLO41018FHK HLO41018FHK 2021-12-14 00801741223785 Halo One Thin-Walled Guiding Sheath HLO41035FHK HLO41035FHK 2021-12-14 00801741223815 Halo One Thin-Walled Guiding Sheath HLO51018FHK HLO51018FHK 2021-12-14 00801741223822 Halo One Thin-Walled Guiding Sheath HLO51035FHK HLO51035FHK 2021-12-14 00801741223853 Halo One Thin-Walled Guiding Sheath HLO61035FHK HLO61035FHK 2021-12-14 00801741223907 Halo One Thin-Walled Guiding Sheath HLO61018FHK HLO61018FHK 2021-12-14 00801741184826 Halo One™ Thin-Walled Guiding Sheath HLO42535H HLO42535H 2020-04-27 00801741184857 Halo One™ Thin-Walled Guiding Sheath HLO52535H HLO52535H 2020-04-27 00801741184871 Halo One™ Thin-Walled Guiding Sheath HLO62535H HLO62535H 2020-04-27 00801741223792 Halo One Thin-Walled Guiding Sheath HLO42518HK HLO42518HK 2021-12-14 00801741223808 Halo One Thin-Walled Guiding Sheath HLO42535HK HLO42535HK 2021-12-14 00801741223839 Halo One Thin-Walled Guiding Sheath HLO52518HK HLO52518HK 2021-12-14 00801741223846 Halo One Thin-Walled Guiding Sheath HLO52535HK HLO52535HK 2021-12-14
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 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 00868260000211 WavelinQ TVA MEDICAL, INC. PQK 2018-08-27
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