AeroPace Neurostimulation Console

Basic Information

• Brand Name: AeroPace Neurostimulation Console
• Primary DI: 00810073210127
• Version / Model: 000-0055
• Company Name: Lungpacer Medical USA Inc.
• Labeler DUNS: 080998049
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-10
• Public Version: 1
• Public Version Date: 2025-03-18
• Public Version Status: New
• Public Device Record Key: b6555dcb-4a08-4060-a42b-8ba21944e204

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
SDL	Transvenous Temporary Phrenic Nerve Stimulator	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
62679	Transvenous phrenic nerve electrical stimulation control unit	An electrically-powered device designed to configure/deliver stimulation of the phrenic nerve, via a transvenous electrode, to cause contraction of the diaphragm in conjunction with mechanical ventilation to assist earlier ventilation weaning. It consists of a pulse generator and a graphical user interface to adjust settings.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810073210127	GS1

Premarket Submissions

Submission Number	Supplement Number
P240012	000