WiSE CRT System

GUDID 00859244007005

Transmitter

EBR Systems, Inc.

Left-ventricular wireless pacing system sensor/transmitter

• Primary Device ID: 00859244007005
• NIH Device Record Key: 129a25ea-9e6a-4f58-89ac-441c6b8eb052
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WiSE CRT System
• Version Model Number: 4100
• Company DUNS: 151420580
• Company Name: EBR Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 4087201906
• Email: ebr.ra@ebrwise.com
• Phone: 4087201906
• Email: ebr.ra@ebrwise.com
• Phone: 4087201906
• Email: ebr.ra@ebrwise.com
• Phone: 4087201906
• Email: ebr.ra@ebrwise.com
• Phone: 4087201906
• Email: ebr.ra@ebrwise.com
• Phone: 4087201906
• Email: ebr.ra@ebrwise.com
• Phone: 4087201906
• Email: ebr.ra@ebrwise.com
• Phone: 4087201906
• Email: ebr.ra@ebrwise.com
• Phone: 4087201906
• Email: ebr.ra@ebrwise.com
• Phone: 4087201906
• Email: ebr.ra@ebrwise.com
• Phone: 4087201906
• Email: ebr.ra@ebrwise.com
• Phone: 4087201906
• Email: ebr.ra@ebrwise.com
• Phone: 4087201906
• Email: ebr.ra@ebrwise.com
• Phone: 4087201906
• Email: ebr.ra@ebrwise.com
• Phone: 4087201906
• Email: ebr.ra@ebrwise.com
• Phone: 4087201906
• Email: ebr.ra@ebrwise.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Devices should be stored in their original packages in a dry, clean environment. Allow devices to acclimate to room temperature prior to implanting.
• Special Storage Condition, Specify: Between 0 and 0 *Devices should be stored in their original packages in a dry, clean environment. Allow devices to acclimate to room temperature prior to implanting.
• Special Storage Condition, Specify: Between 0 and 0 *Devices should be stored in their original packages in a dry, clean environment. Allow devices to acclimate to room temperature prior to implanting.
• Special Storage Condition, Specify: Between 0 and 0 *Devices should be stored in their original packages in a dry, clean environment. Allow devices to acclimate to room temperature prior to implanting.
• Special Storage Condition, Specify: Between 0 and 0 *Devices should be stored in their original packages in a dry, clean environment. Allow devices to acclimate to room temperature prior to implanting.
• Special Storage Condition, Specify: Between 0 and 0 *Devices should be stored in their original packages in a dry, clean environment. Allow devices to acclimate to room temperature prior to implanting.
• Special Storage Condition, Specify: Between 0 and 0 *Devices should be stored in their original packages in a dry, clean environment. Allow devices to acclimate to room temperature prior to implanting.
• Special Storage Condition, Specify: Between 0 and 0 *Devices should be stored in their original packages in a dry, clean environment. Allow devices to acclimate to room temperature prior to implanting.
• Special Storage Condition, Specify: Between 0 and 0 *Devices should be stored in their original packages in a dry, clean environment. Allow devices to acclimate to room temperature prior to implanting.
• Special Storage Condition, Specify: Between 0 and 0 *Devices should be stored in their original packages in a dry, clean environment. Allow devices to acclimate to room temperature prior to implanting.
• Special Storage Condition, Specify: Between 0 and 0 *Devices should be stored in their original packages in a dry, clean environment. Allow devices to acclimate to room temperature prior to implanting.
• Special Storage Condition, Specify: Between 0 and 0 *Devices should be stored in their original packages in a dry, clean environment. Allow devices to acclimate to room temperature prior to implanting.
• Special Storage Condition, Specify: Between 0 and 0 *Devices should be stored in their original packages in a dry, clean environment. Allow devices to acclimate to room temperature prior to implanting.
• Special Storage Condition, Specify: Between 0 and 0 *Devices should be stored in their original packages in a dry, clean environment. Allow devices to acclimate to room temperature prior to implanting.
• Special Storage Condition, Specify: Between 0 and 0 *Devices should be stored in their original packages in a dry, clean environment. Allow devices to acclimate to room temperature prior to implanting.
• Special Storage Condition, Specify: Between 0 and 0 *Devices should be stored in their original packages in a dry, clean environment. Allow devices to acclimate to room temperature prior to implanting.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859244007005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P240028

FDA Product Code

• SEG: Leadless Cardiac Resynchronization Therapy (Crt)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-15
• Device Publish Date: 2025-05-07

On-Brand Devices [WiSE CRT System]

• 00859244007043: Receiver Electrode Delivery Catheter
• 00859244007296: Programmer
• 00859244007067: Delivery Sheath
• 00859244007029: Battery
• 00859244007005: Transmitter