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
1623990277
Device Listing 1623990277
Listing Summary
#
Listing key
1623990277
Premarket submission
K190114
Device
Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)
Applicant
Convatec Limited
Product code
KNT
Decision date
2019-04-30
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
36186
9618003
3003264198
Courtney Smith
1
N
2026-01-01
20 Maguire Lexington, MA MA US 03841
36187
1000317571
1000317571
Courtney Smith
1
N
2026-01-01
20 Maguire Lexington, MA MA US 03841
114444
3008806809
3008806809
Courtney Smith
1
N
2026-01-01
20 Maguire Lexington, MA MA US 03841
186047
3011987967
3011987967
ConvaTec, Inc.
1
Y
2026-01-01
7815 National Service Road Suite 600 Greensboro NC US 27409
199726
3012881740
3012881740
Courtney Smith
1
N
2026-01-01
20 Maguire Lexington, MA MA US 03841