NeuRx Diaphragm Pacing System

GUDID 00852184003007

Synapse Biomedical, Inc.

Intramuscular diaphragm/phrenic nerve electrical stimulation system

• Primary Device ID: 00852184003007
• NIH Device Record Key: 5d69db34-862e-45d8-8cc5-10bad82e9e1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuRx Diaphragm Pacing System
• Version Model Number: 20-0035
• 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: false
• Manufacturing Date: true
• 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	00852184003007 [Primary]

FDA Product Code

• OIR: Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

Sterilization

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

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

Devices Manufactured by Synapse Biomedical, Inc.

• 00852184003588 - Disposable Electrode Delivery Tool: 2021-03-24
• 00852184003618 - 2 Pack, Electrode Delivery Tool Kit: 2021-03-24
• 00852184003007 - NeuRx Diaphragm Pacing System: 2018-03-29
• 00852184003007 - NeuRx Diaphragm Pacing System: 2018-03-29
• 00852184003014 - NeuRx DPS™ System Kit: 2018-03-29
• 00852184003021 - NeuRx DPS™ System Kit, ALS CE: 2018-03-29
• 00852184003038 - NeuRx DPS™ Surgical Kit, HDE: 2018-03-29
• 00852184003045 - NeuRx DPS Patient Kit: 2018-03-29
• 00852184003052 - NeuRx DPS™ Patient Kit, 1 EPG: 2018-03-29