NeuRx DPS™ Surgical Kit

GUDID 00852184003229

Synapse Biomedical, Inc.

Intramuscular diaphragm/phrenic nerve electrical stimulation system lead Percutaneous electrical stimulation lead external pulse generator cable, reusable Percutaneous electrical stimulation lead external pulse generator cable, reusable Percutaneous electrical stimulation lead external pulse generator cable, reusable Percutaneous electrical stimulation lead external pulse generator cable, reusable Percutaneous electrical stimulation lead external pulse generator cable, reusable Percutaneous electrical stimulation lead external pulse generator cable, reusable Percutaneous electrical stimulation lead external pulse generator cable, reusable Percutaneous electrical stimulation lead external pulse generator cable, reusable Percutaneous electrical stimulation lead external pulse generator cable, reusable Percutaneous electrical stimulation lead external pulse generator cable, reusable Percutaneous electrical stimulation lead external pulse generator cable, reusable Percutaneous electrical stimulation lead external pulse generator cable, reusable Percutaneous electrical stimulation lead external pulse generator cable, reusable Percutaneous electrical stimulation lead external pulse generator cable, reusable Percutaneous electrical stimulation lead external pulse generator cable, reusable Percutaneous electrical stimulation lead external pulse generator cable, reusable

• Primary Device ID: 00852184003229
• NIH Device Record Key: c39c63bb-c74b-4721-9134-f10d9c1487b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuRx DPS™ Surgical Kit
• Version Model Number: 20-0018
• 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: true
• Lot Batch: true
• Serial Number: false
• 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	00852184003229 [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
• 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