remede EL System Implantable Pulse Generator IS-1

Basic Information

• Brand Name: remede EL System Implantable Pulse Generator IS-1
• Primary DI: 00857688007391
• Version / Model: 1100
• Company Name: RESPICARDIA, INC.
• Labeler DUNS: 027887663
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-20
• Public Version: 1
• Public Version Date: 2021-08-30
• Public Version Status: New
• Public Device Record Key: 1b779935-8655-4d38-9fbd-46b8c50e2c8e

Device Description

remede EL System, implantable pulse generator for phrenic nerve stimulation, IS-1 header

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PSR	Implanted Phrenic Nerve Stimulator For Central Sleep Apnea	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	00857688007391	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P160039	006