FDA UDI
In Commercial Distribution
🇺🇸 United States
Vena Camera Control Unit
DI: 07540292000126
·
Model: GI-SYS-001
·
Vena Medical Holdings Corp.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vena Camera Control Unit
- Primary DI
- 07540292000126
- Version / Model
- GI-SYS-001
- Company Name
- Vena Medical Holdings Corp.
- Labeler DUNS
- 203888110
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-17
- Public Version
- 2
- Public Version Date
- 2026-03-03
- Public Version Status
- Update
- Public Device Record Key
- 526e4209-3966-4309-bf28-1639ef09dba0
Device Description
The Vena Camera Control Unit (CCU) is the compact, reusable imaging processor part of the Vena MicroAngioscope System.
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
- Yes
- 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 |
|---|---|---|---|---|
| LYK | Angioscope | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44913 | Flexible video angioscope | An endoscope with a very thin, flexible inserted portion intended for the visual examination and treatment of the lumen and patency of blood vessels (especially to evaluate the patency of veins or arteries). It is inserted into the body through an artificial orifice created by an incision. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end and the images showing on a monitor. It is typically used for visualization of the coronary arteries, an arterial bypass procedure with a saphenous vein, or a valvulotomy. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540292000126 | GS1 |