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gammaCore Refill Card 10-Day

electroCore, Inc. · Model 10016-43110 · UDI-DI 00815203020041

PKRQAK Prescription
9
510(k) clearances
1
Adverse events
0
Recalls
1
Facilities

Description

Based on the prescription from their HCP, GammaCore Sapphire users may request / receive a "gammaCore Refill Card" to refill the doses on their device. When requested, the Refill Card will be provided to the user / along with one to six additional tubes of conductive gel (number of tubes provided is based on the 10, 31, or 93 day refill being provided). On receipt of the Refill Card, the user refills the gammaCore device by placing the Card across the face of the device (with the device turned on). The device will display “rd” and the "refill" icon as the device reads the Card. The device will signal (beeping twice) when it has been loaded with the programmed doses. The device is now ready to be used for treatment. Each Refill Card can only be used for one refill; upon completion of the device refill the card may be thrown away.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.