Fisher & Paykel Healthcare, Ltd.

Lots 110810 and 111020

Anesthesiology Devices

1

No

Worldwide Distribution - USA including IL, IN, AR and GA.

Fisher & Paykel Healthcare reusable breathing circuit. || Non-heated breathing circuit, 1.8m or 6 feet in length. || Oxygen therapy delivery system for adult patient.

Lot 121210: December 10th, 2012. Lot 121221: December 21st, 2012.

Anesthesiology Devices

2

No

Worldwide distribution: USA (nationwide) and countries of: Canada, Japan, and Taiwan.

Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). || Models: || ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ. || ICON Novo: ICONNAN, ICONNAN-HT, ICONNAJ. || ICON Premo: ICONPBN, ICONPBN-HT, ICONPBN-HTC. || The ICON CPAP unit is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The device is for use in the home or sleep laboratory. The device is not intended to be used as a life supporting device.