Clinician Connector Kit

Primary DI
00852184003427
Brand
Clinician Connector Kit
Company
Synapse Biomedical, Inc.
Model
22-0029
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852184003427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852184003427008521840034278521840034270852184003427

GMDN Terms#

Term, Definition table
TermDefinition
Intramuscular diaphragm/phrenic nerve electrical stimulation systemAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
138432070
Device count
1
Kit
true
Lot or batch
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