AeroPace Neurostimulation Console

GUDID 00810073210127

Lungpacer Medical USA Inc.

Transvenous phrenic nerve electrical stimulation control unit

• Primary Device ID: 00810073210127
• NIH Device Record Key: b6555dcb-4a08-4060-a42b-8ba21944e204
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AeroPace Neurostimulation Console
• Version Model Number: 000-0055
• Company DUNS: 080998049
• Company Name: Lungpacer Medical USA Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00810073210127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P240012

FDA Product Code

• SDL: Transvenous Temporary Phrenic Nerve Stimulator

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-18
• Device Publish Date: 2025-03-10

Devices Manufactured by Lungpacer Medical USA Inc.

• 00810073210004 - AeroPace Neurostimulation Catheter Kit: 2025-03-18
• 00810073210028 - AeroPace Catheter Cable: 2025-03-18
• 00810073210035 - AeroPace Airway Sensor Cable: 2025-03-18
• 00810073210042 - AeroPace Handheld Controller: 2025-03-18
• 00810073210080 - AeroPace Airway Sensor: 2025-03-18
• 00810073210103 - AeroPace Neurostimulation Console Cart: 2025-03-18
• 00810073210127 - AeroPace Neurostimulation Console: 2025-03-18
• 00810073210127 - AeroPace Neurostimulation Console: 2025-03-18