Therakos UVAR XTS Procedural Kits

IVD products

XT125 Procedural Kit (X752-X760 and Y701-Y753) and XT001 Procedural Kit (X919 and Y901-Y911)

Gastroenterology-Urology Devices

3

No

Worldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD,TN, TX, UT, VA, VT, WA, and WI; and countries of: Argentina, Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Korea, Kingdom of Saudi Arabia, Jordan, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Singapore, Spain, Sweden, Switzerland, Turkey and United Kingdom.

XT125 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENT; XT001 PHOTOPHERESIS PROCEDURAL KIT FOR USE WITH THE UVAR XTS INSTRUMENT || Single-use, disposable, closed system with sterile fluid pathways. The device collects the buffy coat (leukocyte-enriched blood) from the patient in a discontinuous flow process and intermittenly returns the remaining plasma and erythocytes to the patient.

Lots Y703 through Y707 and Y709 though Y726  Lot Number - Expiration Date Y703, 1/1/2015 Y704, 2/1/2015 Y705, 2/1/2015 Y706, 2/1/2015 Y707, 2/1/2015 Y709, 2/1/2015 Y710, 3/1/2015 Y711, 3/1/2015 Y712, 3/1/2015 Y713, 3/1/2015 Y714, 3/1/2015 Y715, 3/1/2015 Y716, 3/1/2015 Y717, 4/1/2015 Y718, 4/1/2015 Y719, 4/1/2015 Y720, 4/1/2015 Y721, 4/1/2015 Y722, 4/1/2015 Y723, 4/1/2015 Y724, 4/1/2015 Y725, 5/1/2015; and Y726, 5/1/2015.

Gastroenterology-Urology Devices

3

No

Worldwide Distribution

Therakos UVAR XTS Procedural Kits || Is indicated for use in the ultraviolet-A (UVA) irradiation.