Summary (PDF - 356KB)

							                                             Biotife Pla~ma Services L.P.

                                Division of BAXTER HEALTHCARE CORPORAnON

                                             One Baxter Parkway 01"3-1 E

                                                 Deerfield, II.., 60015

                                                  Tel: 847-940-5146

                                                 FAX: 847-94{)-5150





510(k) Statement/Statement of Device Safety and Effectiveness

                          BioLife Plasma Services L.P.

                          Donor Information System - Version 3.3


 "In the event that the computerized Donor Information System is marketed, I certify that
 in my capacity as Senior Manager, Regulatory Affairs for BioLife Plasma Services L.P.,
 I will make available all information included in this submission on safety and
 effectiveness within 30 days of request by any person if the device described in this
 submission is determined to be substantially equivalent.

 The information I agree to make available will be a duplicate of the submission,
 including any adverse safety and effectiveness information, but excluding all donor
 identifiers, trade secrets, and confidential commercial information, as defined in 21 CFR
 20.61."




 Julie Quick                                                                               Date
 Sf. Manag , Regulatory Affairs




           This document contains confidential and proprietary information of Baxter Healthcare Corporation.

                                    Do not distribute without written permission.