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 |