FDA UDI
In Commercial Distribution
🇺🇸 United States
WiSE CRT System
DI: 00859244007067
·
Model: 2000
·
EBR Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- WiSE CRT System
- Primary DI
- 00859244007067
- Version / Model
- 2000
- 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
- de5c99c3-43b0-435b-b79d-c9edc8658fba
Device Description
Delivery Sheath
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
- 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
- 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 |
|---|---|---|---|---|
| 63187 | Left-ventricular wireless pacing system transducer/electrode | A device consisting of an endocardial electrode with an ultrasound transducer intended to be implanted within the left ventricle of the heart to receive ultrasound (US) pulses from a parent transmitter and convert these into electrical pacing impulses to pace the left ventricle for cardiac resynchronization therapy (CRT) with a separate co-implanted pacemaker. It consists of a small electrode with a transducer intended to be attached to the endocardium. It is intended as an alternative to left-ventricular pacing using a coronary venous pacing lead. Disposable devices dedicated to implantation (e.g., delivery catheter) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859244007067 | GS1 |
Customer Contacts
- Phone
- 4087201906
- [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, room temperature environment.