NeuRx DPS™ Pacing System, European CE Patient Kit

GUDID 00852184003519

Synapse Biomedical, Inc.

Intramuscular diaphragm/phrenic nerve electrical stimulation system external pulse generator

• Primary Device ID: 00852184003519
• NIH Device Record Key: c52ab5ef-7f60-417a-be59-d7bcb90e4c8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuRx DPS™ Pacing System, European CE Patient Kit
• Version Model Number: 20-0025
• Company DUNS: 138432070
• Company Name: Synapse Biomedical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852184003519 [Primary]

FDA Product Code

• OIR: Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-09-24

On-Brand Devices [NeuRx DPS™ Pacing System, European CE Patient Kit]

• 00852184003519: 20-0025
• 00852184003236: 20-0024