Data / Medical devices / United States / Unetixs Vascular, Inc.
Unetixs Vascular, Inc.: FDA-registered device maker in Warwick, RI, United States, 1 510(k) clearance
Unetixs Vascular, Inc. is registered with the FDA (registration 1222117) in Warwick, RI, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 29, 1991. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1222117
- Address
- 333 Strawberry Field Rd Suite 11, Warwick, RI, United States, 02886
- Owner or operator
- UNETIXS VASCULAR, INC. (9000359)
- Roles
- Manufacturer
- First device listed
- April 14, 2008
- Registered through
- 2026
- Brand names listed
- Miltilab Series 2 LHS-TI, MultiLab 2000 Series 2 Roodra, MultiLab 2000 Series II 2CP-R, MultiLab 2000 Series II 2CP-R Express, MultiLab 2000 Series II LHS-TI, MultiLab 2000 Series II LHS-TI w/Ergo IDC, MultiLab 2000 Series II Revo w/cart, MultiLab 2000 Series II Roodra and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Monitor, Ultrasonic, Nonfetal | JAF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 29, 1991 | K904392 | MULTILAB 2000 | JAF | Substantially Equivalent | Unetixs, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 10, 2023 | 91564 | Class II | Ongoing | MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01 | The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism. | accessdata.fda.gov |
Compare with other makers
Updated March 1, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.