FDA UDI
In Commercial Distribution
🇺🇸 United States
VIVO System
DI: 00851424007119
·
Model: 9002
·
Catheter Precision, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VIVO System
- Primary DI
- 00851424007119
- Version / Model
- 9002
- Catalog Number
- 9002
- Company Name
- Catheter Precision, Inc.
- Labeler DUNS
- 131845013
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-03
- Public Version
- 1
- Public Version Date
- 2026-02-11
- Public Version Status
- New
- Public Device Record Key
- af2fc992-28ee-43c7-8665-937de7ebaaf6
Device Description
VIVO™ uses standard clinical inputs and proprietary algorithms to create patient-specific anatomy, provide a 3D image of the heart with a superimposed activation map, and accurately identify the earliest onset of the arrhythmia. The VIVO™ software comes loaded on a Laptop PC and includes the 3D camera and required accessories.
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
- No
- 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 |
|---|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | Cardiovascular | 870.1425 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44783 | Cardiac mapping system application software | An individual software program or group of programs, routines and/or algorithms that add specific image processing and/or analysis capabilities to a cardiac mapping system computer for storing, processing and management of electronic information/data used to interpret cardiac physiology parameters. It is a basic set of application programs and routines used for cardiac mapping computer-controlled imaging which can be upgraded to correct programming errors or to add new system capabilities. An application program package is typically identified by a proprietary name and "version" or "upgrade" number. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851424007119 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200313 | 000 |