Home GUDID 16936733735968 Angioway
Primary DI 16936733735968
Brand Angioway
Company Lepu Medical Technology (Beijing) Co.,Ltd.
Model LP-P-30-YNP40
Device description Inflation Device Kits is indicated for use in percutaneous coronary Intervention (PCI) treatment (such as percutaneous coronary angioplasty, PTCA; stent Implantation operation) provides the pressure inside the balloon.
Published 2018-05-23
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 PTL Wire, Guide, Catheter, Exempt
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PTL Wire, Guide, Catheter, Exempt Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 16936733735968 Package GS1 5 In Commercial Distribution 06936733735961 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 16936733735968 16936733735968 06936733735961 06936733735961 6936733735961
GMDN Terms# Term, Definition table Term Definition Catheter/overtube balloon inflator, single-use A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.
Regulatory Flags# DUNS number 529853921 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 36927675513480 RADIFOCUS Terumo Medical Products (Hangzhou) Co., Ltd. PTL 2022-12-08 00860003987353 Speed-Torque® Vascugenix, LLC PTL 2022-11-03 00860003987360 Speed-Torque® Vascugenix, LLC PTL 2022-11-03 10860003987350 Speed-Torque® Vascugenix, LLC PTL 2022-11-03 10860003987367 Speed-Torque® Vascugenix, LLC PTL 2022-11-03 06947358544302 Sunmed guidewire torque device Sunny Medical Device (Shenzhen) Co., Ltd. PTL 2022-01-04 00860003987315 Speed Torque Vascugenix, LLC PTL 2021-02-03 00860003987322 Speed Torque Vascugenix, LLC PTL 2021-02-03 00860003987339 Speed Torque Vascugenix, LLC PTL 2021-02-03 00860003987346 Speed Torque Vascugenix, LLC PTL 2021-02-03 00884450458068 SeaDragon2™ Merit Medical Systems, Inc. PTL 2020-08-14 10884450458065 SeaDragon2™ Merit Medical Systems, Inc. PTL 2020-08-14 06936733735923 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 06936733735930 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 06936733735947 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 06936733735954 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 06936733735961 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 06936733735978 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 06936733736043 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 06936733736050 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 06936733736067 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 06936733736074 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 06936733736081 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 06936733736098 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 16936733735937 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 16936733735951 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 16936733736040 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 16936733736064 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 16936733736088 Angioway Lepu Medical Technology (Beijing) Co.,Ltd. PTL 2018-05-23 00884450007792 Pin Vise Merit Medical Systems, Inc. PTL 2016-09-26