FDA UDI
In Commercial Distribution
🇺🇸 United States
Unetixs Vascular
DI: B437129500
·
Model: Multilab 2000 Series 2 Revo
·
UNETIXS VASCULAR, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Unetixs Vascular
- Primary DI
- B437129500
- Version / Model
- Multilab 2000 Series 2 Revo
- Catalog Number
- 12950-0000-01
- Company Name
- UNETIXS VASCULAR, INC.
- Labeler DUNS
- 625463146
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-27
- Public Version
- 1
- Public Version Date
- 2023-03-07
- Public Version Status
- New
- Public Device Record Key
- caf5377f-65f6-435e-8ead-5a9ebbf53bd7
Device Description
The Revo is intended for use as a non-invasive diagnostic device by trained medical personnel following physician orders. This device is intended for the detection of obstruction to blood flow in human arteries and veins as an aid for the diagnosis of disease in the peripheral vascular 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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| JAF | Monitor, Ultrasonic, Nonfetal | Radiology | 892.1540 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13056 | Limb plethysmograph | A graphic recorder designed for determining and registering volume variations in the extremities (legs/toes and/or arms/fingers) as modified by the circulation of blood through them. It typically consists of flow and/or volume sensors and transducers attached to an electronic unit, which processes the data and displays the results. It may operate using one of several methods including venous occlusion (pneumatic), photoelectric, electrical impedance, or strain gauge. The device is typically used in peripheral vascular diagnostic investigations [e.g., for deep vein thrombosis (DVT) or arterial occlusive disease]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B437129500 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K904392 | 000 |