Surface Electrode, Single-Pack

Primary DI
00852184003441
Brand
Surface Electrode, Single-Pack
Company
Synapse Biomedical, Inc.
Model
22-0031
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
OIRDiaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIRDiaphragmatic/Phrenic Nerve Laparoscopically-Implanted StimulatorUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852184003441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852184003441008521840034418521840034410852184003441

GMDN Terms#

Term, Definition table
TermDefinition
Intramuscular diaphragm/phrenic nerve electrical stimulation system leadA non-sterile, insulated metal wire(s) that enables an electrical connection between an intramuscular diaphragm/phrenic nerve electrical stimulation system external pulse generator (EPG) and the proximal ends of the implanted electrodes to permit the transmission of the electrical pulses and to create a return path to the EPG. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-767-3770customerservice@synapsebiomedical.com

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 DIBrandModelCatalogPublished
008521840036182 Pack, Electrode Delivery Tool Kit20-00742021-03-16
00852184003007NeuRx Diaphragm Pacing System20-00352014-09-24
00852184003038NeuRx DPS™ Surgical Kit, HDE20-00282014-09-24
00852184003045NeuRx DPS Patient Kit20-00362014-09-24
00852184003090STERILE Mapping Probe21-0001-992014-09-24
00852184003106STERILE Indifferent Electrode21-0004-992014-09-24
00852184003113STERILE Lead Tunnelers21-0007-992014-09-24
00852184003120STERILE Blue Cable Set21-0009-992014-09-24
00852184003137STERILE Trocar to Transducer Tubing21-0010-992014-09-24
00852184003144STERILE PermaLoc Electrode, 60cm21-0017-992014-09-24
00852184003151STERILE Touchproof Cable, Green21-0023-992014-09-24
00852184003168STERILE Touchproof Cable, Orange21-0024-992014-09-24
00852184003175STERILE Touchproof Cable Yellow21-0025-992014-09-24
00852184003182STERILE Touchproof Cable, White21-0026-992014-09-24
00852184003199NeuRx DPS™ Surgical Site Start-up Kit, SCI HDE20-00072014-09-24
00852184003212NeuRx DPS™ External Pulse Generator23-00212014-09-24
00852184003267Spare Surgical Kit20-00402014-09-24
00852184003298System Destination Kit, SCI HDE, US20-00612014-09-24
00852184003342Connector Holder Kit22-00042014-09-24
00852184003366Patient Cable22-00112014-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852184003588Disposable Electrode Delivery ToolSynapse Biomedical, Inc.OIR2021-03-16
008521840036182 Pack, Electrode Delivery Tool KitSynapse Biomedical, Inc.OIR2021-03-16
00852184003007NeuRx Diaphragm Pacing SystemSynapse Biomedical, Inc.OIR2014-09-24
00852184003014NeuRx DPS™ System KitSynapse Biomedical, Inc.OIR2014-09-24
00852184003021NeuRx DPS™ System Kit, ALS CESynapse Biomedical, Inc.OIR2014-09-24
00852184003038NeuRx DPS™ Surgical Kit, HDESynapse Biomedical, Inc.OIR2014-09-24
00852184003045NeuRx DPS Patient KitSynapse Biomedical, Inc.OIR2014-09-24
00852184003052NeuRx DPS™ Patient Kit, 1 EPGSynapse Biomedical, Inc.OIR2014-09-24
00852184003069System Destination Kit, CE 2 EPGSynapse Biomedical, Inc.OIR2014-09-24
00852184003076System Destination Kit, ALS CESynapse Biomedical, Inc.OIR2014-09-24
00852184003083NeuRx DPS™ Surgical Site Start-up KitSynapse Biomedical, Inc.OIR2014-09-24
00852184003090STERILE Mapping ProbeSynapse Biomedical, Inc.OIR2014-09-24
00852184003106STERILE Indifferent ElectrodeSynapse Biomedical, Inc.OIR2014-09-24
00852184003113STERILE Lead TunnelersSynapse Biomedical, Inc.OIR2014-09-24
00852184003120STERILE Blue Cable SetSynapse Biomedical, Inc.OIR2014-09-24
00852184003137STERILE Trocar to Transducer TubingSynapse Biomedical, Inc.OIR2014-09-24
00852184003144STERILE PermaLoc Electrode, 60cmSynapse Biomedical, Inc.OIR2014-09-24
00852184003151STERILE Touchproof Cable, GreenSynapse Biomedical, Inc.OIR2014-09-24
00852184003168STERILE Touchproof Cable, OrangeSynapse Biomedical, Inc.OIR2014-09-24
00852184003175STERILE Touchproof Cable YellowSynapse Biomedical, Inc.OIR2014-09-24
00852184003182STERILE Touchproof Cable, WhiteSynapse Biomedical, Inc.OIR2014-09-24
00852184003199NeuRx DPS™ Surgical Site Start-up Kit, SCI HDESynapse Biomedical, Inc.OIR2014-09-24
00852184003205NeuRx DPS™ Clinical Station Kit, HDESynapse Biomedical, Inc.OIR2014-09-24
00852184003212NeuRx DPS™ External Pulse GeneratorSynapse Biomedical, Inc.OIR2014-09-24
00852184003229NeuRx DPS™ Surgical KitSynapse Biomedical, Inc.OIR2014-09-24
00852184003236NeuRx DPS™ Pacing System, European CE Patient KitSynapse Biomedical, Inc.OIR2014-09-24
00852184003243NeuRx DPS™ System Kit, CanadaSynapse Biomedical, Inc.OIR2014-09-24
00852184003250Clinical Station KitSynapse Biomedical, Inc.OIR2014-09-24
00852184003267Spare Surgical KitSynapse Biomedical, Inc.OIR2014-09-24
00852184003274Anode Replacement Parts KitSynapse Biomedical, Inc.OIR2014-09-24