AccessGUDID - DEVICE: WiSE CRT System (00859244007005)

GUDID

Device Identifier (DI) Information

Brand Name: WiSE CRT System
Version or Model: 4100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EBR Systems, Inc.

Primary DI Number: 00859244007005
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 151420580 *Terms of Use

Device Description: Transmitter

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
SEG	Leadless Cardiac Resynchronization Therapy (Crt)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P240028	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 129a25ea-9e6a-4f58-89ac-441c6b8eb052
Public Version Date: May 15, 2025
Public Version Number: 1
DI Record Publish Date: May 07, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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