FDA UDI
In Commercial Distribution
🇺🇸 United States
NUVISION NAV Ultrasound Catheter
DI: 10846835025194
·
Model: FG11656
·
Biosense Webster Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NUVISION NAV Ultrasound Catheter
- Primary DI
- 10846835025194
- Version / Model
- FG11656
- Catalog Number
- FG11656
- Company Name
- Biosense Webster Inc
- Labeler DUNS
- 020163218
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-03
- Public Version
- 1
- Public Version Date
- 2023-07-11
- Public Version Status
- New
- Public Device Record Key
- 9af900e2-e6bc-49bb-b549-30ceff37dad4
Device Description
NUVISION NAV Ultrasound Catheter, 10F
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| 42584 | Intracardiac ultrasound imaging catheter, steerable, single-use | A steerable, flexible tube with an ultrasonic phased-array imaging transducer at its distal tip designed for intracardiac echocardiography to enable intracardiac and possibly great vessel (e.g., pulmonary artery) visualization for the assessment of cardiac anatomy and physiology, and visualization of other devices in the heart; it is not intended for peripheral vascular or coronary artery insertion/imaging. It is introduced percutaneously, and includes controls to allow it to be manoeuvred (steerable). It is connected to a compatible ultrasound system for transmission and display of the images. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10846835025194 | GS1 |
Customer Contacts
- Phone
- +1(800)729-9010
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223766 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Liquid-tight (catheter shaft only)
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from Sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 60 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use if package is damaged
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -22 – 140 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use if package is opened
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protection against vertically dripping water drops (catheter handle only)