WiSE CRT System

Basic Information

• Brand Name: WiSE CRT System
• Primary DI: 00859244007029
• Version / Model: 3100
• 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: f2752c2a-0711-4138-9139-e225c7590044

Device Description

Battery

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
63189	Implantable pacemaker battery	A hermetically-sealed, implantable, electrochemical cell designed to store chemical energy and release it in the form of electrical power to operate a co-implanted pacing device (e.g., pacemaker, wireless pacemaker sensor/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	00859244007029	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.