FDA UDI
In Commercial Distribution
🇺🇸 United States
Venovo®
DI: 00801741103575
·
Model: VENUM16080
·
Angiomed GmbH & Co. Medizintechnik KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Venovo®
- Primary DI
- 00801741103575
- Version / Model
- VENUM16080
- Catalog Number
- VENUM16080
- Company Name
- Angiomed GmbH & Co. Medizintechnik KG
- Labeler DUNS
- 320047483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-18
- Public Version
- 2
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- aa4e4feb-a20f-493c-84c3-e134880d21d5
Device Description
Venovo® Venous Stent System 16 mm x 80 mm (80 cm delivery catheter)
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
- Yes
- MRI Safety
- MR Conditional
- 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 |
|---|---|---|---|---|
| QAN | Stent, iliac vein | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58057 | Iliofemoral vein stent | A non-bioabsorbable tubular device intended to be implanted in an iliac and/or femoral vein to maintain patency in patients with constrained venous outflow. It is inserted and advanced to the site of implantation with a dedicated catheter where it self-expands upon release. The device is typically made of nickel-titanium alloy (Nitinol) and has radiopaque marker(s) for visualization; it is available in a variety of diameters and lengths. Disposable devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00801741103575 | GS1 |
Customer Contacts
- Phone
- +1(800)321-4254
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Catheter Length, 80 Centimeter | ||
| Device Size Text, specify | Implant Diameter, 16 Millimeter | ||
| Device Size Text, specify | Implant Length, 80 Millimeter |