WiSE CRT System

Basic Information

• Brand Name: WiSE CRT System
• Primary DI: 00859244007005
• Version / Model: 4100
• Company Name: EBR Systems, Inc.
• Labeler DUNS: 151420580
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-07
• Public Version: 1
• Public Version Date: 2025-05-15
• Public Version Status: New
• Public Device Record Key: 129a25ea-9e6a-4f58-89ac-441c6b8eb052

Device Description

Transmitter

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 Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• 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
SEG	Leadless Cardiac Resynchronization Therapy (Crt)	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
63188	Left-ventricular wireless pacing system sensor/transmitter	A hermetically-sealed device intended to be implanted beneath the skin of the chest in a surgically-created pocket to: 1) sense signals from a separate co-implanted pacemaker; and 2) generate and transmit synchronized ultrasound (US) pulses to a left-ventricular endocardial transducer/electrode (not included). The US pulses will be converted into electrical pacing impulses and synchronized with the co-implanted pacemaker to achieve cardiac resynchronization therapy (CRT). It consists of a small unit with sensing electrodes and an ultrasound generator/transmitter. Disposable devices dedicated to implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859244007005	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P240028	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Devices should be stored in their original packages in a dry, clean environment. Allow devices to acclimate to room temperature prior to implanting.