510k Blood Establishment Computer Software
Software is listed in alphabetical order by applicant.
Applicant | Device Name | 510(k) Number | Clearance Date |
Abbott Laboratories 100 Abbott Park Road Abbott Park, IL 60064 |
Abbott Apheresis Tracking System (AARTS) Version 1.0 | BK950048 | 6/24/1998 |
Abbott Laboratories 100 Abbott Park Road Abbott Park, IL 60064 |
Abbott DMS II Version 1.5 | BK950052 | 8/12/1998 |
Abbott Laboratories 100 Abbott Park Road Abbott Park, IL 60064 |
Abbott DMS Version 3.0.2 | BK950032 | 8/18/1998 |
Abbott Laboratories 100 Abbott Park Road Abbott Park, IL 60064-3500 |
Abbott Prism Retest | BK010036 | 7/17/2002 |
ADAC HealthCare Information System 5 Greenway Plaza, Suite 1900 Houston, TX 77046 |
LabCare Blood Bank II Version 13.3 | BK960027 | 8/12/1998 |
American Blood Resources Association PO Box 669 Annapolis, MD 21404 |
National Donor Deferral Registry Version 2.0 | BK960030 | 3/20/1997 |
American Blood Resources Association 147 Old Solomons Island Road Annapolis, MD 21401 |
National Donor Deferral Registry Ver 1.0 | BK010012 | 9/6/2001 |
American Red Cross Washington, DC 20006 |
National Biomedical Computer System, Version 1.1 | BK960040 | 2/28/1997 |
American Red Cross Blood Services Arlington, VA 22209 |
NGTL Automation system (NAS) 5.2.0 | BK020032 | 3/20/2003 |
Bayer Corp 800 Dwight Way Berkeley, CA 94701 |
Plasma Procurement Information System Version 2.0 | BK960051 | 8/7/1998 |
Bayer Corp 800 Dwight Way Berkeley, CA 94701 |
Plasma Procurement Information System (PPIS), version 3.0 | BK990024 | 11/3/1999 |
Bayer Corp 800 Dwight Way Berkeley, CA 94701 |
Plasma Procurement Information System (PPIS), version 4.0 | BK990037 | 11/17/1999 |
Baxter Healthcare Corp 550 North Brand Blvd Glendale, CA 91203 |
Serology SQL LIMS 1.0 | BK020002 | 8/7/2002 |
Becton, Dickinson & Company 1 Becton Drive, MC 300 Franklin Lakes NJ 07417-1885 |
Bd.id Patient Identification System for Transfusion Management V7.00 | BK060046 | 2/13/2007 |
BioLife Plasma Services LP One Baxter Parkway Deerfield IL 60015 |
Donor Information System (DIS) 3.2 | BK060017 | 5/9/2006 |
BioLife Plasma Services LP One Baxter Parkway Deerfield IL 60015 |
Donor Information System (DIS) 3.1 | BK050029 | 7/7/2005 |
Blood Bank Computer Systems, Inc 1002 15th SW, Suite 120 Auburn, WA 98001-6502 |
BBCS Lab Interface Application (BBCS Lab) 5.0L | BK040087 | 2/15/2005 |
Blood Bank Computer Systems, Inc 1002 15th SW, Suite 120 Auburn, WA 98001-6502 |
Blood Bank Control System (BBCS) 5.0 | BK040056 | 10/22/2004 |
Blood Bank Computer Systems, Inc 1501 West Valley Hwy, Suite 101 Auburn, WA 98001 |
Blood Bank Control System Version 4.0/4.1/4.2/4.3 | BK960044 | 10/15/1997 |
Care Fusion, Inc. 1430 Spring Hill Road, Suite 510 McLean, VA 22102 |
wBlood Care 1.0 | BK040002 | 11/10/2004 |
Carter BloodCare 2205 Highway 121 Bedford, TX 76021 |
LifeTrak / Distribution, version 2.03 | BK990015 | 10/22/1999 |
Carter BloodCare 2205 Highway 121 Bedford, TX 76021 |
LifeTrak / Donor, version 2.03 | BK990027 | 12/15/1999 |
Cerner Corp 2800 Rockcreek Parkway Kansas City, MO 64117 |
PathNet Blood Bank Center Version 306 | BK950051 | 7/16/1997 |
Cerner Corp 2800 Rockcreek Parkway Kansas City, MO 64117 |
PathNet Blood Bank Transfusion Version 306 | BK950053 | 7/16/1997 |
Cerner Corp 2800 Rockcreek Parkway Kansas City, MO 64117 |
PathNet Blood Bank Donor Version 306 | BK950055 | 7/16/1997 |
Cerner Corp 2800 Rockcreek Parkway Kansas City, MO 64117 |
PathNet Worksystems Blood Bank Transfusion Version 306 | BK960024 | 7/16/1997 |
Cerner Corp 2800 Rock Creek Parkway Kansas City, MO 64117 |
HNA Millennium PathNet Blood Bank Transfusion | BK990007 | 11/2/1999 |
Cerner Corp 2800 Rock Creek Parkway Kansas City, MO 64117 |
Cerner Millennium PathNet Blood Bank Donor (PA-22200) 2003.01 | BK030028 | 8/19/2003 |
Cerner Corp 2800 Rock Creek Parkway Kansas City, MO 64117 |
Cerner Bridge Medical Transfusion Administration and Specimen Collections 3.3 | BK060037 | 5/24/2007 |
Chiron Corporation 4560 Horton Street Emeryville CA 94608-2916 |
Chiron Procleix NAT Tracker 3.0 | BK060005 | 3/1/2006 |
Community Bio-Resources, Inc 2197 Parkway Lake Drive Hoover, AL 35244 |
Donor Information System Version 1.0 | BK970007 | 4/9/1997 |
Community Blood Center of Greater Kansas City 4040 Main Street Kansas City, MO 64117 |
CBC Blood System Version 1.2 | BK960060 | 11/20/1997 |
Data Innovations, Inc. 120 Kimball Ave., Suite 100 South Burlington, VT 05430 |
Instrument Manager 8.05.01.10 | BK060053 | 1/5/2007 |
Data Innovations, Inc. 120 Kimball Ave., Suite 100 South Burlington, VT 05430 |
imExpress 7.2.5 | BK020057 | 7/29/2003 |
Department of Defense 5 Skyline Plaza Falls Church, VA 22047 |
Defense Blood Standard System Versions 1.00/1.03 | BK960004 | 8/1/1997 |
Department of Defense 5113 Leesburg Pike, Suite 701 Falls Church, VA 22041 |
Defense Blood Standard System Version 3.00 | BK980031 | 8/31/1998 |
Department Of Veterans Affairs P.O. Box 7008 Hines IL 60141-7008 |
VistA Blood Establishment Computer Software (VBECS) 1.0 | BK060043 | 10/19/2006 |
Department Of Veterans Affairs P.O. Box 5000 VA Hines Medical Center Hines, IL 60141 |
Vista Blood Bank, Version 5.2 | BK970021 | 4/23/1999 |
Digi-Trax 1550 Barclay Blvd Buffalo Grove, IL 60089 |
Donor - ID Version 1.0 | BK970013 | 2/27/1998 |
Digi-Trax 1550 Barclay Blvd Buffalo Grove, IL 60089 |
Digi-Trax Donor-ID Version 2.0 | BK000020 | 4/20/2000 |
Digi-Trax 1550 Barclay Blvd Buffalo Grove, IL 60089 |
Donor-ID 2.2 | BK010049 | 4/26/2002 |
Duley Hopkins and Associates 1200 Mountain Creek Road Chattanooga , TN 37405 |
Blood Bank Information Management System (BBIMS) | BK070065 | 4/25/2008 |
Dynamic Healthcare Techonologies, Inc 101 Southhall Lane, Suite 210 Maitland, FL 32751 |
Transfusion Service Manager Version 4.1.6 | BK960041 | 12/16/1997 |
Fifth Dimension Information Systems Suite 500, 10025- 102A Avenue Edmonton, Alberta T5J 2Z2 CANADA |
E-Interview (eQue) 1.0.0 | BK050060 | 5/24/2006 |
Fifth Dimension Information Systems Suite 500, 10025- 102A Avenue Edmonton, Alberta T5J 2Z2 CANADA |
LOGIC 2.0 | BK040040 | 10/6/2004 |
Fifth Dimension Information Systems Suite 500 Midland Walwyn Tower Edmonton Centre Edmonton, Alberta Canada T5J2Z2 |
Plasma Center Module, Version 1.0 | BK980025 | 5/18/1999 |
Fifth Dimension Information Systems Suite 500 Merril Lynch Tower Edmonton Centre Edmonton, Canada |
Donor Management System, version 1.0.0 | BK990022 | 9/10/1999 |
Fifth Dimension Information Systems Suite 500 Edmonton, Alberta Cananda T5J2Z2 |
P2K Plasma Center Module 2000 Version 1.0 | BK000026 | 6/22/2000 |
Fifth Dimension Information Systems Suite 500, Merril Lynch Tower Edmonton Centre Edmonton, Alberta, T5J 2Z2 CANADA |
LOGIC 1.0 | BK020058 | 2/3/2003 |
Gambro BCT, Inc 10811 W. Collins Ave Lakewood, CO 80215-4498 |
Vista Information System, Independent Solution | BK020015 | 7/15/2002 |
Gambro BCT, Inc 10811 W. Collins Ave Lakewood, CO 80215-4498 |
Vista Information System 2.1 | BK030021 | 5/1/2003 |
GE Medical Information Technologies 540 Northwest Highway Barrington, IL 60010 |
Centricity Ultra Laboratory Transfusion Medicine (Ultra TM) 4.0 | BK050018 | 6/13/2005 |
Healthcare-ID 1635 Barclay Blvd Buffalo Grove IL 60089 |
Donor-ID 3.0 | BK060058 | 2/8/2007 |
Healthcare-ID 1635 Barclay Blvd. Buffalo Grove, IL 60089 |
Donor-ID version 2.5 | BK030049 | 10/31/2003 |
Healthcare Management Systems, Inc 3102 West End Avenue, Suite 400 Nashville TN 37203 |
Monitor Blood Administration Module Release 24.0 | BK050001 | 9/28/2005 |
Helmer Labs, Inc 15425 Herriman Boulevard Noblesville, IN 46060 |
UltraCW (with Software version 3.13) | BK020029 | 10/4/2002 |
Information Data Management, Inc 9701 West Higgins Rd Rosemont, IL 60018 |
IDM Symphony System 2.0 | BK070031 | 12/13/2007 |
Information Data Management, Inc 9701 West Higgins Rd Rosemont, IL 60018 |
Components and Distribution Information System Version 1.0 | BK950037 | 8/26/1996 |
Information Data Management, Inc 9701 West Higgins Rd Rosemont, IL 60018 |
Donor Mgmt. Information System Version 1.2 | BK950045 | 8/26/1996 |
Information Data Management, Inc 9701 West Higgins Road Rosemont, IL 60018 |
Plasma Center Management System Version 1.0 | BK980020 | 7/31/1998 |
Information Data Management, Inc 9701 West Higgins Road Rosemont, IL 60018 |
Plasma Center Management System Version 1.1 | BK980028 | 9/4/1998 |
Information Data Management, Inc 9701 West Higgins Road Rosemont, IL 60018 |
Surround System 1.0 | BK990016 | 8/27/1999 |
Information Data Management, Inc 9701 West Higgins Road Rosemont, IL 60018 |
Plasma Center Management System (PCMS), Version 1.2 | BK990029 | 10/13/1999 |
Information Data Management, Inc 9701 West Higgins Road Rosemont, IL 60018 |
Plasma Center Management System (PCMS), Version 2.0 | BK990046 | 1/6/2000 |
Information Data Management, Inc 9701 West Higgins Road Rosemont, IL 60018 |
Surround System 2.0 | BK000016 | 4/7/2000 |
Information Data Management Systems, Inc 9701 west Higgins Road Rosemont, IL 60018 |
Surround System, Version 3.2 | BK020038 | 10/8/2002 |
Information Data Management, Inc 9701 West Higgins Road Rosemont, IL 60018 |
IDM Prelude System, Version 1.1 | BK0500014 | 7/18/2005 |
Informedics, Inc 4000 Kruse Way Place, Building 3 Lake Oswego, OR 97035 |
Lifeline Blood Bank Management System Release 4.2 | BK950064 | 7/1/1998 |
Korchek Technologies, LLC 770 Plattsville Road Trumbull CT 06611 |
CareChek Patient Identification System, CareChek, Version 1.0 | BK040053 | 8/12/2005 |
LifeSouth Community Blood Centers Inc 4039 W. Newberry Road Gainesville FL 32607 |
Integrated Blood Bank Information System (IBBIS) Registration Module v1.0 | BK080017 | 8/5/2008 |
LifeTrak/BloodCare 9000 Harry Hines Blvd. Dallas, TX 75235 |
Lab Version 2.01 | BK940048 | 10/1/1998 |
MAK System 10 Avenue de la Grande Armee Paris, France |
Patient Health Software 1.0 | BK060035 | 5/9/2007 |
MAK System Z.1. Paris Nord II 13, Rue de la Perdix B.P. 50035 95946 Roissy C.D.G. CEDEX, France |
Progesa, Version 4.4a | BK960050 | 12/10/1998 |
Medical Information Technology Meditech Circle Westwood, MA 02090 |
Meditech Magic Blood Bank, Version 4.5/4.6 | BK960029 | 3/19/1999 |
Medical Information Technology Meditech Circle Westwood, MA 02090 |
Magic Client Server, Version 5.1 | BK980046 | 2/8/2000 |
Mediware Information Systems, Inc 4545 Fuller Drive, Ste 320 Irving, TX 75038 |
LifeTrak / Donor 3.01 | BK060019 | 6/21/2006 |
Mediware Information Systems, Inc 4545 Fuller Drive, Ste 320 Irving, TX 75038 |
HCLL Donor 1.0 | BK050011 | 5/10/2005 |
Mediware Information Systems, Inc 4545 Fuller Drive, Ste 320 Irving, TX 75038 |
Instrument Interface Engine 1.0 | BK040047 | 7/16/2004 |
Mediware Information Systems, Inc 4545 Fuller Drive, Ste 320 Irving, TX 75038 |
HCLL 2.6 | BK030078 | 4/8/2004 |
Mediware Information Systems, Inc 9000 Harry Hines Blvd Dallas, TX 75235 |
LifeTrak Lab 2.03 | BK010052 | 6/17/2002 |
Mediware Information Systems, Inc 1121 Old Walt Whitman Road Melville, NY 11747 |
Hemocare Blood Bank Management System Version 5.2 | BK980034 | 12/10/1998 |
Mediware Information Systems, Inc 900 Oakmont Lane Westmont, IL, 60659 |
Hemocare LifeLine Version, 1.0 | BK020046 | 2/14/2003 |
Medserv, Inc 71 South Bedford Road Mount Kisco, NY 10549 |
Plasmapheresis Data System III 1.0 | BK010032 | 2/5/2002 |
Misys Healthcare Systems 4801 East Broadway Boulevard Tucson, AZ 85711 |
Misys Laboratory Blood Bank and Blood Donor 6.0.1 | BK040065 | 10/22/2004 |
Mosum Technology India PVT LTD 55 Northern Blvd, Suite 200 Great Neck NY 11021 |
PowerBANK Enterprise Edition version 1.0 | BK060014 | 3/30/2007 |
Neoteric Technology Ltd 205-1099 W. 8th Ave. Vancouver British Columbia V6H 1C3 CANADA |
BloodTrack 4.1 | BK060041 | 10/17/2006 |
Ortho-Clinical Diagnostics, Inc 1001 U.S. Highway 202 Raritan, NJ 08869 |
Ortho Lab with Ortho Lab IC (Instrument Concentrator), Version 1.0 | BK990030 | 4/3/2000 |
Prescott Ideas LLC 8960 E. Anna Place Tucson AZ 85710 |
Antibody Check 4.1 | BK060056 | 4/23/2007 |
Psyche Systems Corp Ten Laurel Avenue Wellesley, MA 02481 |
System Blood Bank (SBB) Ver. 3.0 | BK010017 | 9/4/2001 |
Rubin & Poor, Inc 155 Maplewood Avenue #5 Maplewood, NJ 07040 |
Pool Results Manager Version 1.0C, Module for Roche NAT Testing Version 2.0A | BK080028 | 9/3/2008 |
Rubin & Poor, Inc 155 Maplewood Avenue #5 Maplewood, NJ 07040 |
Configurable Manual Batch Entry, Verion 1.1A | BK030073 | 1/14/2004 |
Rubin & Poor, Inc 155 Maplewood Avenue #5 Maplewood, NJ 07040 |
Configurable Laboratory Result Manager (CLRM) 1.0E | BK000030 | 11/23/2001 |
Rubin & Poor, Inc 150 West 25th Street, Suite 600 New York, NY 10001 |
Rubin & Poor Configurable Manual Blot System, version 1.0C | BK990008 | 10/29/1999 |
Rubin & Poor, Inc 155 Maplewood Avenue #5 Maplewood, NJ 07040 |
Chiron Procleix NAT Tracker 1.0E | BK010025 | 1/3/2002 |
Sanguin International 1020 Sherman Avenue Hamden, CT 06514 |
Medussa 2000 Srimport, version 1.2 | BK980039 | 6/11/1999 |
SCC Soft Computer 5400 Tech Data Drive Clearwater FL 33760 |
SoftBank II v23.2 | BK080020 | 8/12/2008 |
SCC Soft Computer 34350 US Highway 19 North Palm Harbor, FL 34684 |
SoftDonor 4.3 with SoftScape 1.2.0 | BK050045 | 10/26/2005 |
Shared Medical Systems 51 Valley Stream Parkway Malvern, PA 19355 |
SMS Blood Bank Transfusion System Versions 2.0/3.0/4.0 | BK960036 | 12/12/1997 |
Soft Computer Consultant 34350 US Highway 19 North Palm Harbor, FL 34684 |
Softbank II Version 19.1 | BK960033 | 7/10/1998 |
Soft Computer Consultants 34350 US Highway 19 North Palm Harbor, FL 34684 |
Softbank II Version 21.1 | BK000040 | 4/20/2001 |
Soft Computer Consultants, Inc 34350 U.S. HWY 19 N Palm Harbor, FL 34684 |
SoftBank II 22 | BK020021 | 9/11/2002 |
Soft Computer Consultants, Inc 34350 U.S. Hwy 19 N Palm Harbor, FL, 34684 |
SoftDonor 4.1 | BK020006 | 2/27/2003 |
Soft Computer Consultants, Inc 34350 U.S. HWY 19 N Palm Harbor, FL 34684 |
SoftBank II 23 | BK030018 | 4/17/2003 |
Soft Computer Consultants, Inc 34350 U.S. HWY 19 N Palm Harbor, FL 34684 |
SoftBank II version 23 with SoftScape | BK040028 | 5/7/2004 |
Sunquest Information Systems 4801 Broadway Boulevard Tucson, AZ 85711 |
Flexilab Blood Bank and Blood Donor, Version 5.2 | BK990002 | 8/16/1999 |
Sunquest Information Systems, Inc 4801 Broadway Boulevard Tucson, AZ 85711 |
FlexiLab Blood Bank and Blood Donor System, version 5.2 | BK990034 | 11/17/1999 |
Systec Computer Associates, Inc 28 North Country Road Mt. Sinai, NY 11766 |
LifeTec Elite 1.0 | BK060032 | 8/21/2006 |
Systec Computer Associates, Inc 28 North Country Road Mt. Sinai, NY 11766 |
LifeTec Donor Verification and Collection System (DOVAC) 1.00 | BK040026 | 10/21/2004 |
Systec Computer Associates, Inc 28 North Country Road Mt. Sinai, NY 11766 |
LifeTec, Version 2.20 | BK990003 | 7/30/1999 |
SysTec Computer Associates 28 North Country Road Mt. Sinai, NY 11766 |
LifeTec Community Blood Center System Revision 2.10 | BK960034 | 7/28/1998 |
Talisman Ltd 421 Church Street NE. Suite F Vienna VA 22180 |
Quality Donor System v2.1 | BK070020 | 7/16/2007 |
Talisman Ltd 421 Church Street NE. Suite F Vienna, VA 22180 |
Talisman Phlebotomy System, Release 1.0 | BK060031 | 7/27/2006 |
Talisman Ltd 421 Church Street NE. Suite F Vienna, VA 22180 |
Quality Donor System 2004 2.0 | BK040062 | 10/18/2004 |
Wyndgate Technologies 4925 Robert J. Matthews Parkway Suite 100 El Dorado Hills CA 95762 |
ElDorado Donor 1.0.0 | BK070064 | 2/13/2008 |
Wyndgate Technologies 4925 Robert J. Matthews Parkway Suite 100 El Dorado Hills CA 95762 |
ElDorado Donor Doc 1.0.0 | BK070010 | 5/23/2007 |
Wyndgate Technologies 11121 Sun Center Drive, Suite C Rancho Cordova, CA 95670 |
Safe Trace Version 1.0 | BK950059 | 4/14/1997 |
Wyndgate Technologies 111212 Sun Center Drive, Suite C Rancho Cordova, CA 95670 |
SafeTrace TX, Version 1.0 | BK980023 | 1/29/1999 |
ZLB Behring AG Wankdorfstrasse 10 Bern, Switzerland |
System for Plasma Identification (SPI) 2.0.0 | BK050078 | 12/22/2005 |
ZLB Bioplasma AG Wannkdorfstrasse 10 Bern, Switzerland |
System for Plasma Identififcation (SPI) 1.0 | BK020020 | 10/30/2002 |