Device, Iontophoresis, Other Uses

IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.

The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.

IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080;

The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.

Hidrex USA DP450

The device was reclassified from a class III device to a class II device and there are new documentation requirements.

Hidrex USA DVP1000

The device was reclassified from a class III device to a class II device and there are new documentation requirements.

Daavlin Aquex (DAAV1000)

The device was reclassified from a class III device to a class II device and there are new documentation requirements.

Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product is packaged in 12 treatment kit box labeled as Buffered Iontophoretic D

The conductor portion of the electrode is installed backwards, with the plastic and silver portions of the electrode reversed.

iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box. Dosage: 1

The dosage information on the pouch is incorrect; the primary carton label is correct.