FDA UDI
In Commercial Distribution
🇺🇸 United States
FlexNav™
DI: 05415067031372
·
Model: FNAV-DS-SM
·
ST. JUDE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FlexNav™
- Primary DI
- 05415067031372
- Version / Model
- FNAV-DS-SM
- Catalog Number
- FNAV-DS-SM
- Company Name
- ST. JUDE MEDICAL, INC.
- Labeler DUNS
- 149818952
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-20
- Public Version
- 1
- Public Version Date
- 2021-09-28
- Public Version Status
- New
- Public Device Record Key
- 52e5e381-60b9-4f14-9287-cc6281626cf1
Device Description
Delivery System
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| NPT | Aortic valve, prosthesis, percutaneously delivered | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63283 | Transcatheter heart valve bioprosthesis implantation catheter | A flexible tube intended to be used to deploy and implant a heart valve bioprosthesis (not included) during a minimally invasive transcatheter procedure via transarterial access (e.g., femoral, subclavian, aortic) under fluoroscopic guidance. It typically consists of a proximal handpiece with controls for positioning and deployment of the valve, and may be designed for deployment of a self-expanding bioprosthesis or include a balloon for dilation of an expandable bioprosthesis. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05415067031372 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 18.0000 | French | |
| Length | 107.0000 | Centimeter |