Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1643396694
Device Listing 1643396694
Listing Summary
#
Listing key
1643396694
Premarket submission
K191252
Device
Gem FlowCoupler System
Applicant
Baxter/ Synovis Micro Companies Alliance, Inc.
Product code
MVR
Decision date
2019-07-09
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
189044
1062741
3000302153
SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.)
1
Y
2026-01-01
439 Industrial Ln BIRMINGHAM AL US 35211
2232
1416980
1416980
BAXTER HEALTHCARE CORPORATION
1
N
2026-01-01
25212 W. ILLINOIS ROUTE 120 ROUND LAKE IL US 60073
188734
2183620
2183620
SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.)
1
N
2026-01-01
2575 University Ave W Saint Paul MN US 55114