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  1. Approved Blood Products

510(k) Blood Establishment Computer Software - 2018

510(k) Blood Establishment Computer Software - 2018

Software is listed by clearance date in reverse chronological order.

510(k) Number Applicant Device Name Decision Date
BK180245 Data Innovations LLC
120 Kimball Avenue, Suite 100
South Burlington, VT 05430
Instrument Manager V8.16.10 11/8/2018
BK180240 Biomat USA, Inc.
2410 Lillyvale Avenue
Los Angeles, CA 90032-3514
GDS (Grifols Donation System), version 1.0 11/5/2018
BK180246 Carter BloodCare
2205 Highway 121
Bedford, TX
Blood Bank Information System (BBIMS) version 2.06.00 11/1/2018
BK180232 MAK-SYSTEM SA International Group
10 Avenue de la Grande-Armée
Paris, France 75017
Patient Health Software (P.H.S) Version 2.0 10/18/2018
BK180227 Department of Veterans Affairs
P.O. Box 7008
5th Avenue and Roosevelt Road (Building 37)
Hines, IL 60141
VistA Blood Establishment Computer (VBECS) Version 2.3.0 10/1/2018
BK180219 Medical Information Technology, Inc.
Meditech Circle
Westwood, MA 02090
MEDITECH Expanse Blood Bank 9/12/2018
BK180209 Haemonetics Corporation
400 Wood Road
Braintree, MA 02184-9114
SafeTrace Tx 4.0.0 8/7/2018
BK180200 Mediware Information Systems, Inc.
11711 West 79th Street
Lenexa, KS
LifeTrak® 2018 7/3/2018
BK170162 Grifols Diagnostic Solutions, Inc.
4560 Horton Street
Emeryville, CA 94608
Procleix Xpress® System (Software v3.0) 1/18/2018