Vaccines, Blood & Biologics

510(k) Blood Establishment Computer Software - 2018

Software is listed by clearance date in reverse chronological order.

510(k) NumberApplicantDevice NameDecision Date
BK180245Data Innovations LLC
120 Kimball Avenue, Suite 100
South Burlington, VT 05430
Instrument Manager V8.16.1011/8/2018
BK180240Biomat USA, Inc.
2410 Lillyvale Avenue
Los Angeles, CA 90032-3514
GDS (Grifols Donation System), version 1.011/5/2018
BK180246Carter BloodCare
2205 Highway 121
Bedford, TX 76021
Blood Bank Information System (BBIMS) version 2.06.0011/1/2018
BK180232MAK-SYSTEM SA International Group
10 Avenue de la Grande-Armée
Paris, France 75017
Patient Health Software (P.H.S) Version 2.010/18/2018
BK180227Department of Veterans Affairs
P.O. Box 7008
5th Avenue and Roosevelt Road (Building 37)
Hines, IL 60141
VistA Blood Establishment Computer (VBECS) Version 2.3.010/1/2018
BK180219Medical Information Technology, Inc.
Meditech Circle
Westwood, MA 02090
MEDITECH Expanse Blood Bank9/12/2018
BK180209Haemonetics Corporation
400 Wood Road
Braintree, MA 02184-9114
SafeTrace Tx 4.0.08/7/2018
BK180200Mediware Information Systems, Inc.
11711 West 79th Street
Lenexa, KS
LifeTrak® 20187/3/2018
BK170162Grifols Diagnostic Solutions, Inc.
4560 Horton Street
Emeryville, CA 94608
Procleix Xpress® System (Software v3.0)1/18/2018


Page Last Updated: 11/14/2018
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