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Sign in to claim this brandU.S. Infusion, LLC
US
Last updated May 30, 2026
What U.S. Infusion, LLC makes
U.S. Infusion, LLC manufactures basic intravenous administration sets designed for noninvasive use, as well as Luer-formatted protective caps. These products are intended for fluid delivery and connection security in medical settings, ensuring compatibility with standard intravenous systems.
The company’s products fall under FDA Class II devices and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates within the United States, adhering to applicable U.S. regulatory requirements for medical devices.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does U.S. Infusion, LLC manufacture?
U.S. Infusion, LLC specializes in basic intravenous administration sets for noninvasive use and Luer-formatted protective caps. These devices are primarily designed for fluid delivery in medical settings and connection security, ensuring compatibility with standard intravenous systems. The focus is on foundational components used in intravenous therapy.
Where is U.S. Infusion, LLC based?
U.S. Infusion, LLC is based in the United States. The company operates within the U.S. regulatory framework, which governs the design, manufacturing, and distribution of its medical devices to ensure compliance with applicable standards and requirements.
Which regulatory registries list U.S. Infusion, LLC’s devices?
U.S. Infusion, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators.
How are U.S. Infusion, LLC’s devices classified by the FDA?
U.S. Infusion, LLC’s devices fall under FDA Class II classification. This classification is assigned based on the level of risk associated with the device—Class II devices generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- tcbiomedix.com
- —
- —
- [email protected]
- Phone
- (866) 593-8444
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 005457284
Catalogue (77)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| TrueCare Biomedix | TCBPTT013S | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBINF6480 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBCOMBICAP | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBINFSP1 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBINF022AE | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBINF6571 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBINF044G | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBCOMBICAP | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBINF6481 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBEXTNF-E | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBPTTH-2LL | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBINF6537 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBPTTH-2LL | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBINF6481 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBEXT004 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBINF6480 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBPTTHBC01 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBINFGSB12 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBINF120SC | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBSYR20B | FDA UDI | Class II | Unknown |
| TrueCare Biomedix | TCBINF6200 | FDA UDI | Class II | Unknown |
| TrueCare Biomedix - USA | TCBTEC-10R | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBEXT001 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBINF120SC | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBEXT001 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBINF6519 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBPTTPS1 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBSYR3B | FDA UDI | Class II | Unknown |
| TrueCare Biomedix | TCBEXT1.2 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBINF121SC | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBEXT003 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBPTT021 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBINFGSB12 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBINF6537 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBPTT331 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBPTT001 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBPTT021 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBPTT001 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBINF6419 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBINF044G | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBPTT331 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBPTT062 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBINF2NFRB | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBEXTNF | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBINF033G | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBEXT0.2 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBEXT003 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBEXT004 | FDA UDI | Class II | Active |
| TrueCare Biomedix | TCBSYR60C-30 | FDA UDI | Class II | Unknown |
| TrueCare Biomedix | TCBSYR60C-30 | FDA UDI | Class II | Unknown |
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