Sentec NIMH25004491
Summary
AI-generated · Sep 05, 2025The requirement centers on the Sentec V-Sign Sensor and ancillary supplies, a digital device for noninvasive, continuous monitoring of tcPCO?, SpO?, pulse rate, and relative heating power (RHP). It is suitable for a broad patient range—from neonates to adults—and can be used in NICU/PICU, sleep labs, and postoperative care environments.
Key points include noninvasive, continuous monitoring as the core capability, with accompanying ancillary supplies to support ongoing use. The device is described as state-of-the-art and applicable across diverse clinical settings and patient populations.
The Sentec V-Sign Sensor + ancillary supply are a state-of-the-art digital device designed for noninvasive, continuous monitoring of transcutaneous carbon dioxide tension (tcPCO?), pulse oximetry (SpO?), pulse rate, and relative heating power (RHP). It caters to a wide range of patients, including neonates, children, and adults, and is suitable for various clinical settings such as neonatal and pediatric intensive care units (NICU/PICU), sleep labs, and post-operative care
From Special Notice posted on Sep 03, 2025Notice history
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Agency
Place of Performance
USA