NeuRx DPS™ Pacing System, European CE Patient Kit

Basic Information

• Brand Name: NeuRx DPS™ Pacing System, European CE Patient Kit
• Primary DI: 00852184003519
• Version / Model: 20-0025
• Company Name: Synapse Biomedical, Inc.
• Labeler DUNS: 138432070
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: c52ab5ef-7f60-417a-be59-d7bcb90e4c8b

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OIR	Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
47812	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852184003519	GS1