Home GUDID 00857688007278 Respiguide Delivery System
Primary DI 00857688007278
Brand Respiguide Delivery System
Company RESPICARDIA, INC.
Model 7120-S
Device description Respiguide Delivery System, 35 cm Outer Guide Catheter with 120 degree bend Distal shape; 65 cm Inner Angiographic Catheter with Straight Distal Shape
Published 2018-04-30
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 DQO Catheter, Intravascular, Diagnostic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQO Catheter, Intravascular, Diagnostic Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10857688007275 Package GS1 5 In Commercial Distribution 00857688007278 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 10857688007275 10857688007275 00857688007278 00857688007278 857688007278 0857688007278
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.
Regulatory Flags# DUNS number 027887663 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00857688007384 respistim LQS Stimulation Lead, Additional Proximal Tubing 4165 2020-10-09 00857688007001 remede System Implantable Pulse Generator 1001 2018-04-30 00857688007063 respistim R Stimulation Lead 3102 2018-04-30 00857688007070 respistim R Stimulation Lead 3103 2018-04-30 00857688007230 respistim LQS Stimulation Lead 4065 2018-04-30 00857688007315 remede System Programmer 1002A 2018-04-30 00857688007322 remede System Programming Wand 1004A 2018-04-30 00857688007339 remede System Flexible Programming Wand 1004A-F 2018-04-30 00857688007346 remede System External Pulse Generator 1006 2018-04-30 00857688007391 remede EL System Implantable Pulse Generator IS-1 1100 2021-08-20 00857688007407 remede EL-X System Implantable Pulse Generator Inline Connector 1600 2021-08-20 00857688007414 remede EL/EL-X External Pulse Generator 1006A 2021-08-20 00857688007421 Lead Test Adaptor, remede EL-X 1007 2021-08-20 00857688007438 respistim R Stimulation Lead, Inline Connector 3602 2021-08-20 00857688007445 respistim R Stimulation Lead, Inline Connector 3603 2021-08-20 00857688007452 respistim R Stimulation Lead, Inline Connector 3652 2021-08-20 00857688007469 respistim R Stimulation Lead, Inline Connector 3653 2021-08-20 00857688007483 respistim LQS Stimulation Lead, Inline Connector 4665 2021-08-20 00857688007490 respistim LQS Stimulation Lead, Inline Connector 4685 2021-08-20
Other Devices Sharing Product Codes# 
respicardia.com
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