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
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 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 4 French Device Size Text, specify 0 Device Size Text, specify 0
Regulatory Flags# DUNS number 989214291 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 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 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 00801741223860 Halo One Thin-Walled Guiding Sheath HLO62535HK HLO62535HK 2021-12-14 00801741223914 Halo One Thin-Walled Guiding Sheath HLO62518HK HLO62518HK 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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