FDA.reportPublic FDA data

Intramuscular diaphragm/phrenic nerve electrical stimulation system

Definition
An assembly of battery-powered devices designed to provide ventilatory support to a patient with diaphragm dysfunction of neuromuscular origin through electrical stimulation of the phrenic nerve to contract the diaphragm rhythmically and cause the patient to draw breath in a manner similar to natural breathing. It typically consists of implanted intramuscular electrodes placed in the diaphragm in proximity to the phrenic nerve motor point, an external pulse generator (EPG), and a cable to connect the externally exposed ends of the electrodes with the EPG. The system typically controls parameters such as pulse amplitude, pulse duration, pulse frequency, inspiration time, and respiratory rate.
GUDID devices
39
Last updated
2022-04-01 06:53:01

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07290017249049BioRef-DCTAVGER LTDFG000192022-03-24
00852184003588Disposable Electrode Delivery ToolSynapse Biomedical, Inc.21-0039-992021-03-16
008521840036182 Pack, Electrode Delivery Tool KitSynapse Biomedical, Inc.20-00742021-03-16
00888867343627Arthrex®ARTHREX, INC.AR-95952020-06-25
00852184003007NeuRx Diaphragm Pacing SystemSynapse Biomedical, Inc.20-00352014-09-24
00852184003014NeuRx DPS™ System KitSynapse Biomedical, Inc.20-00302014-09-24
00852184003021NeuRx DPS™ System Kit, ALS CESynapse Biomedical, Inc.20-00312014-09-24
00852184003038NeuRx DPS™ Surgical Kit, HDESynapse Biomedical, Inc.20-00282014-09-24
00852184003045NeuRx DPS Patient KitSynapse Biomedical, Inc.20-00362014-09-24
00852184003052NeuRx DPS™ Patient Kit, 1 EPGSynapse Biomedical, Inc.20-00462014-09-24
00852184003069System Destination Kit, CE 2 EPGSynapse Biomedical, Inc.20-00632014-09-24
00852184003076System Destination Kit, ALS CESynapse Biomedical, Inc.20-00642014-09-24
00852184003083NeuRx DPS™ Surgical Site Start-up KitSynapse Biomedical, Inc.20-00392014-09-24
00852184003113STERILE Lead TunnelersSynapse Biomedical, Inc.21-0007-992014-09-24
00852184003120STERILE Blue Cable SetSynapse Biomedical, Inc.21-0009-992014-09-24
00852184003137STERILE Trocar to Transducer TubingSynapse Biomedical, Inc.21-0010-992014-09-24
00852184003151STERILE Touchproof Cable, GreenSynapse Biomedical, Inc.21-0023-992014-09-24
00852184003168STERILE Touchproof Cable, OrangeSynapse Biomedical, Inc.21-0024-992014-09-24
00852184003175STERILE Touchproof Cable YellowSynapse Biomedical, Inc.21-0025-992014-09-24
00852184003182STERILE Touchproof Cable, WhiteSynapse Biomedical, Inc.21-0026-992014-09-24
00852184003199NeuRx DPS™ Surgical Site Start-up Kit, SCI HDESynapse Biomedical, Inc.20-00072014-09-24
00852184003267Spare Surgical KitSynapse Biomedical, Inc.20-00402014-09-24
00852184003274Anode Replacement Parts KitSynapse Biomedical, Inc.20-00432014-09-24
00852184003281System Kit, ALS HDESynapse Biomedical, Inc.20-00452014-09-24
00852184003298System Destination Kit, SCI HDE, USSynapse Biomedical, Inc.20-00612014-09-24
00852184003304System Destination Kit, ALS HDE, USSynapse Biomedical, Inc.20-00622014-09-24
00852184003311System Destination Kit, 2-EPG, CanadaSynapse Biomedical, Inc.20-00652014-09-24
00852184003328Surgical Site Start-up Kit, ALS HDESynapse Biomedical, Inc.20-00702014-09-24
00852184003342Connector Holder KitSynapse Biomedical, Inc.22-00042014-09-24
00852184003359Silicone Adhesive KitSynapse Biomedical, Inc.22-00092014-09-24
00852184003373Electrode Delivery Tool Kit MedCoat, CESynapse Biomedical, Inc.22-00182014-09-24
00852184003380Extended-Life Battery - 3 PackSynapse Biomedical, Inc.22-00202014-09-24
00852184003397Airline Travel Battery PackSynapse Biomedical, Inc.22-00212014-09-24
00852184003403Clinician Crimp ToolSynapse Biomedical, Inc.22-00222014-09-24
00852184003410Surgical Connector KitSynapse Biomedical, Inc.22-00282014-09-24
00852184003427Clinician Connector KitSynapse Biomedical, Inc.22-00292014-09-24
00852184003434Clinician Connector Repair Parts KitSynapse Biomedical, Inc.22-00302014-09-24
00852184003465Electrode Delivery Tool Kit, MedCoat, HDESynapse Biomedical, Inc.22-00342014-09-24
00852184003496Socket PusherSynapse Biomedical, Inc.23-00102014-09-24