WiSE CRT System

Basic Information

• Brand Name: WiSE CRT System
• Primary DI: 00859244007296
• Version / Model: 5100
• 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: 6368a569-afcb-4fac-86fb-375fbc24af60

Device Description

Programmer

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• 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
SEG	Leadless Cardiac Resynchronization Therapy (Crt)	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
47205	Cardiac pulse generator programmer	An external device intended to enable a healthcare professional in a clinical setting to noninvasively change the settings of, and extract data from, an implanted cardiac pulse generator (e.g., pacemaker, pacemaker/defibrillator). It includes a radio-frequency transmitter/receiver and may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859244007296	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.