FDA UDI
In Commercial Distribution
🇺🇸 United States
NuVision ICE Catheter
DI: 00860005688104
·
Model: FG10593
·
Nuvera Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NuVision ICE Catheter
- Primary DI
- 00860005688104
- Version / Model
- FG10593
- Company Name
- Nuvera Medical, Inc.
- Labeler DUNS
- 117379819
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-07
- Public Version
- 1
- Public Version Date
- 2021-07-15
- Public Version Status
- New
- Public Device Record Key
- 446dfa6b-d5e0-4789-8b7f-3d77ae49b535
Device Description
The NUVISION™ ICE Catheter is a diagnostic ultrasound imaging catheter designed for intracardiac use.
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 |
|---|---|---|---|---|
| OBJ | Catheter, Ultrasound, Intravascular | Cardiovascular | 870.1200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62545 | Cardiac mapping/ultrasound imaging catheter | A sterile, flexible, dual-purpose tube containing an arrangement of electrodes and ultrasonic imaging transducers at its distal tip, designed for: 1) electrophysiological diagnostic examinations such as electrophysiology (EP) mapping, sensing, and recording of cardiac structures; and 2) intracardiac ultrasound for visualization of the cardiac anatomy (inner surface), primarily to support the EP functions. It is introduced percutaneously through a compatible steerable guide catheter (not included) to enable manoeuvring within the cardiac anatomy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860005688104 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201775 | 000 |