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

 

 

 
Updated: September 12 , 2008