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VersaPump Infuser

EMED TECHNOLOGIES CORPORATION · Model FP-0010209 · UDI-DI 00817708023404

PKP Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The VersaPump Infuser is a reusable mechanical, non-electronic infusion pump that does not require batteries or any electrical source. There are no alarms or displays. The VersaPump Infuser uses a spring as a source of energy to provide pressure for the subcutaneous infusion of the indicated human plasma-derived immunoglobulin solutions. The VersaPump Infuser is provided with a carrying case and User Manual. The carrying case allows the user to strap the VersaPump to their shoulder and walk around their environment during an infusion cycle. The VersaPump enclosure is made of synthetic polymer blend of glass reinforced polyphenylene ether and polystyrene, the spring is a 301 stainless steel spring, and the spring enclosure is made of synthetic polymer polyoxymethylene (POM/acetal).

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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.