Custom Ultrasonics, Inc.

All Serial Numbers

2

No

Worldwide; USA medical facilities and physicians and Canada

System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PA

Serial numbers: 051305-J, 061705-E, 061605-F, and 061705-G.

General Hospital and Personal Use Devices

2

No

Worldwide-The device was shipped to medical facilities in CA, GA, VA. and the UK.

83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc.

Multiple serial numbers

2

No

Worldwide Distribution: USA (nationwide) and Internationally to: Canada, Slovakia Republic, Sydney and Peru.

Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector.

All serial numbers

General Hospital and Personal Use Devices

2

No

Nationwide Distribution to IN, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD., ME, MI, MN, MO,MS, MT, NC, NE, NH, NJ, NM, NV, NY OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT,WA, WI, WV, and WY.

The System 83 Plus, Endoscope Washer/Disinfector || Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.