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VIVI CAP SMART

Tempramed · Model 12002025 · UDI-DI 00854073007103

510(k) clearances

Adverse events

Recalls

Facilities

Description

A portable, reusable thermal-insulating device designed to serve as a cap of, or contain, an autoinjector (e.g., insulin pen), in order to maintain its contents within a specific temperature range while being carried by the patient. It is in the form of a small cylinder, which may also function as a cap for the autoinjector, and is made of thermal-insulating material and a phase change material (PCM). It includes electronics that provides indication of medication temperature. Additionally, it has an incorporated timer mechanism to help people know how long it has been since they last took their medication and an optional connected cell phone application used as a log book to store the time information and amount of medication that has been injected.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.