Home GUDID 00852184003243 NeuRx DPS™ System Kit, Canada
Primary DI 00852184003243
Brand NeuRx DPS™ System Kit, Canada
Company Synapse Biomedical, Inc.
Model 20-0032
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 00852184003243 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 00852184003243 00852184003243 852184003243 0852184003243
GMDN Terms# Term, Definition table Term Definition Intramuscular diaphragm/phrenic nerve electrical stimulation system external pulse generator An external, battery-powered device designed to provide electrical signals (pulses), through implanted electrodes, to stimulate the phrenic nerve motor point in the diaphragm and contract the diaphragm rhythmically to cause a patient to draw breath in a manner similar to natural breathing. It is typically a small, body-worn, programmable device [an external pulse generator (EPG)] that is programmed by a healthcare professional; the programs can be altered remotely by telemetric communication with a clinical workstation.
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 00852184003069 System Destination Kit, CE 2 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 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