VeinViewer Flex is designed for ease of use. VeinViewer Flex utilizes visible and near-infrared light for vascular imaging to illuminate and project the subcutaneous venous structure…
VeinViewer Flex is designed for ease of use. VeinViewer Flex utilizes visible and near-infrared light for vascular imaging to illuminate and project the subcutaneous venous structure directly onto a patient’s skin. AVIN™ (Active Vascular Imaging Navigation) allows the user to assess multiple access points with a re al-time digital image.
Who Else Makes It
Concentrated in Shandong (3), Guangdong (3), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for VeinViewer 3.0 Flex | Listed by | Christie Medical Holdings, Inc., United States |
| FDA product code | KZA |
| Device type | Device, Vein Location, Liquid Crystal |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6970 |
| Establishment | Remanufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-14 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature -10 to 140 °F; Handling environment humidity 0 to 90 % RH |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.