Home GUDID 00852184003069 System Destination Kit, CE 2 EPG
Primary DI 00852184003069
Brand System Destination Kit, CE 2 EPG
Company Synapse Biomedical, Inc.
Model 20-0063
Published 2014-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name OIR Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OIR Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00852184003069 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 00852184003069 00852184003069 852184003069 0852184003069
GMDN Terms# Term, Definition table Term Definition Intramuscular diaphragm/phrenic nerve electrical stimulation system 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.
Regulatory Flags# DUNS number 138432070 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00852184003618 2 Pack, Electrode Delivery Tool Kit 20-0074 2021-03-16 00852184003007 NeuRx Diaphragm Pacing System 20-0035 2014-09-24 00852184003038 NeuRx DPS™ Surgical Kit, HDE 20-0028 2014-09-24 00852184003045 NeuRx DPS Patient Kit 20-0036 2014-09-24 00852184003090 STERILE Mapping Probe 21-0001-99 2014-09-24 00852184003106 STERILE Indifferent Electrode 21-0004-99 2014-09-24 00852184003113 STERILE Lead Tunnelers 21-0007-99 2014-09-24 00852184003120 STERILE Blue Cable Set 21-0009-99 2014-09-24 00852184003137 STERILE Trocar to Transducer Tubing 21-0010-99 2014-09-24 00852184003144 STERILE PermaLoc Electrode, 60cm 21-0017-99 2014-09-24 00852184003151 STERILE Touchproof Cable, Green 21-0023-99 2014-09-24 00852184003168 STERILE Touchproof Cable, Orange 21-0024-99 2014-09-24 00852184003175 STERILE Touchproof Cable Yellow 21-0025-99 2014-09-24 00852184003182 STERILE Touchproof Cable, White 21-0026-99 2014-09-24 00852184003199 NeuRx DPS™ Surgical Site Start-up Kit, SCI HDE 20-0007 2014-09-24 00852184003212 NeuRx DPS™ External Pulse Generator 23-0021 2014-09-24 00852184003267 Spare Surgical Kit 20-0040 2014-09-24 00852184003298 System Destination Kit, SCI HDE, US 20-0061 2014-09-24 00852184003342 Connector Holder Kit 22-0004 2014-09-24 00852184003366 Patient Cable 22-0011 2014-09-24
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00852184003588 Disposable Electrode Delivery Tool Synapse Biomedical, Inc. OIR 2021-03-16 00852184003618 2 Pack, Electrode Delivery Tool Kit Synapse Biomedical, Inc. OIR 2021-03-16 00852184003007 NeuRx Diaphragm Pacing System Synapse Biomedical, Inc. OIR 2014-09-24 00852184003014 NeuRx DPS™ System Kit Synapse Biomedical, Inc. OIR 2014-09-24 00852184003021 NeuRx DPS™ System Kit, ALS CE Synapse Biomedical, Inc. OIR 2014-09-24 00852184003038 NeuRx DPS™ Surgical Kit, HDE Synapse Biomedical, Inc. OIR 2014-09-24 00852184003045 NeuRx DPS Patient Kit Synapse Biomedical, Inc. OIR 2014-09-24 00852184003052 NeuRx DPS™ Patient Kit, 1 EPG Synapse Biomedical, Inc. OIR 2014-09-24 00852184003076 System Destination Kit, ALS CE Synapse Biomedical, Inc. OIR 2014-09-24 00852184003083 NeuRx DPS™ Surgical Site Start-up Kit Synapse Biomedical, Inc. OIR 2014-09-24 00852184003090 STERILE Mapping Probe Synapse Biomedical, Inc. OIR 2014-09-24 00852184003106 STERILE Indifferent Electrode Synapse Biomedical, Inc. OIR 2014-09-24 00852184003113 STERILE Lead Tunnelers Synapse Biomedical, Inc. OIR 2014-09-24 00852184003120 STERILE Blue Cable Set Synapse Biomedical, Inc. OIR 2014-09-24 00852184003137 STERILE Trocar to Transducer Tubing Synapse Biomedical, Inc. OIR 2014-09-24 00852184003144 STERILE PermaLoc Electrode, 60cm Synapse Biomedical, Inc. OIR 2014-09-24 00852184003151 STERILE Touchproof Cable, Green Synapse Biomedical, Inc. OIR 2014-09-24 00852184003168 STERILE Touchproof Cable, Orange Synapse Biomedical, Inc. OIR 2014-09-24 00852184003175 STERILE Touchproof Cable Yellow Synapse Biomedical, Inc. OIR 2014-09-24 00852184003182 STERILE Touchproof Cable, White Synapse Biomedical, Inc. OIR 2014-09-24 00852184003199 NeuRx DPS™ Surgical Site Start-up Kit, SCI HDE Synapse Biomedical, Inc. OIR 2014-09-24 00852184003205 NeuRx DPS™ Clinical Station Kit, HDE Synapse Biomedical, Inc. OIR 2014-09-24 00852184003212 NeuRx DPS™ External Pulse Generator Synapse Biomedical, Inc. OIR 2014-09-24 00852184003229 NeuRx DPS™ Surgical Kit Synapse Biomedical, Inc. OIR 2014-09-24 00852184003236 NeuRx DPS™ Pacing System, European CE Patient Kit Synapse Biomedical, Inc. OIR 2014-09-24 00852184003243 NeuRx DPS™ System Kit, Canada Synapse Biomedical, Inc. OIR 2014-09-24 00852184003250 Clinical Station Kit Synapse Biomedical, Inc. OIR 2014-09-24 00852184003267 Spare Surgical Kit Synapse Biomedical, Inc. OIR 2014-09-24 00852184003274 Anode Replacement Parts Kit Synapse Biomedical, Inc. OIR 2014-09-24 00852184003281 System Kit, ALS HDE Synapse Biomedical, Inc. OIR 2014-09-24