Data / Medical devices / United States / Us Infusion LLC. D/B/A Truecare Biomedix-Usa
Us Infusion LLC. D/B/A Truecare Biomedix-Usa: FDA-registered device maker in South Miami, FL, United States, 3 510(k) clearances
Us Infusion LLC. D/B/A Truecare Biomedix-Usa is registered with the FDA (registration 3008782867) in South Miami, FL, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 15, 2021. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008782867
- Address
- 6356 Manor Ln Ste 101, South Miami, FL, United States, 33143
- Owner or operator
- US Infusion LLC. d/b/a Truecare Biomedix-USA (10028886)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 27, 2011
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, Administration, Intravascular | FPA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| September 15, 2021 | K210818 | TrueCare Biomedix Tamper Evident Cap | FMF | Substantially Equivalent | Us Infusion Inc. D/B/A Truecare Biomedix-USA | accessdata.fda.gov |
| June 8, 2012 | K121554 | Q-FLO CLOSED MALE LUER CONNECTOR | FPA | Substantially Equivalent | Us Fusion, LLC. Dba Truecare Biomedix-USA | accessdata.fda.gov |
| September 29, 2011 | K111351 | TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET | FPA | Substantially Equivalent | Us Infusion Dba Truecare Biomedix | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 10, 2014 | 70143 | Class II | Terminated | Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date. | Several complaints regarding the IV sets leaking at the Y site. | accessdata.fda.gov |
Compare with other makers
Updated September 15, 2021. 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.