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
OTC false
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 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.
Regulatory Flags# DUNS number 027887663 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 false Sterilization required before use false 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
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