VitalPatch® VitalConnect Platform
VITAL CONNECT, INC.
Vital Connect, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010830833 | 3010830833 | Vital Connect, Inc. | 1 | N | 2020-04-25 | 224 Airport Parkway Suite 300 San Jose CA US 95110 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 170010 | 1030913529 | K190916 | VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 | DRG | 2019-06-07 |
| 170010 | 1470329699 | K183078 | VitalConnect Platform, VitalPatch Biosensor | DRG | 2019-03-07 |
| 170010 | 1647941501 | K170973 | VitalWatch Software User Interface | DRG | 2017-06-02 |
| 170010 | 1411576999 | K163453 | VitalPatch® VitalConnect Platform | DRG | 2017-11-02 |
| 170010 | 2062618348 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DRG | 4 | 2019-06-07 |
PMN#
Vital Connect Platform, HealthPatch MD, VitalPatch
VITAL CONNECT, INC.
VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY)
VITAL CONNECT INC.
VITALCONNECT PLATFORM BY VITAL CONNECT INC.
Vital Connect, Inc
STEALTHSHIELD
VITAL CONNECTIONS, INC.
ELECTRODE CABLE
VITAL CONNECTIONS, INC.
GUDID#
VitalPatch 2.0 - VitalPatch 2.0, 7 days
2019-07-25
Vital Connections, Inc. - "24"" DIN Plug/Socket 10 Pack White"
2018-02-28
Vital Connections, Inc. - "24"" DIN Plug/Socket 10 Pack Green"
2018-02-28
Holter Kit (Wi-Fi Only) - Contains VistaPhone (Wi-Fi Only) with protective case, charger, charge cable, Adhesive Overlay, Alcohol Wipes, Adhesive Removal Pads
2023-08-31
VistaPhone - Vista Phone S9 relay device
2023-03-31
VistaPhone Compact Cardiac Monitoring Kit - Compact Cardiac Monitoring Kit
2023-03-31
VitalPatch Adhesive Overlay - 3801-01
2019-03-26
VistaPhone - Vista Phone A21 relay device
2021-01-15
Vista Solution® 30-day Monitoring Kit - 9430-01
2020-11-04
Vista Solution® 10-day Evaluation Kit - 9410-01
2020-11-04
Vista Solution® 2.0 10-day Evaluation Kit - 9510-01
2020-11-04
VistaTablet™ 2.0 RELAY (W/O VCI Box) - VistaTablet is a tablet which will be running the VistaPoint software user interface in a Web container
2020-11-04
VitalPatch 2.0 - VitalPatch 2.0, 7 days
2020-11-03
VistaCenter - Multipatient user interface, convenience view of VistaPoint
2020-11-02
VistaPoint Software User Interface - User interface in the patient's room
2020-11-02
VistaTablet - Vista Tablet relay device
2020-11-02
Vista Solution 3 10-day Evaluation Kit - 9610
2020-11-02
VistaTablet - VistaTablet Relay Device
2020-11-02
VistaPhone - Vista Phone relay device
2020-11-02
VitalConnect 14-day Cardiac Monitoring Kit - 1400-02
2020-11-02
VitalPatch® RTM - VitalPatch Biosensor
2020-11-02
VistaTablet - VistaTablet is a tablet which will be running the VistaPoint software user interface in a Web container
2018-08-16
VitalPatch Adhesive Overlay - 3801-01
2019-03-26
HealthPatch® MD Gentle Patch - 1001-01
2016-08-23
HealthPatch® MD Gentle Patch - 1001-01
2016-08-23
HealthPatch® MD Active Patch - 1002-01
2016-08-23
HealthPatch® MD Module - 1025-01
2016-08-23
VistaTablet™ 2.0 (Boxed) - 8102-01
2019-07-25
VitalPatch 2.0 - VitalPatch 2.0, 7 days
2019-07-25
VitalPatch™ 2.0 Single - VitalPatch 2.0 Single
2019-03-18
"""VitalPatch™ Gentle Patch" - 3001-01
2016-08-23
"""VitalPatch™ Active Patch" - 3002-01
2016-08-23
VitalPatch® Active Biosensor - 3012-01
2017-05-04
"VitalPatch™ Gentle Patch - 3001-01
2016-08-23
"VitalPatch™ Active Patch - 3002-01
2016-08-23
VistaCenter - Multipatient user interface, convenience view of VistaPoint
2018-02-20
VitalPatch® Active Biosensor - 3012-01
2017-05-04
VistaPoint Software User Interface - User interface in the patient's room
2018-02-20
VistaHub-WiFi - VistaHub-WiFi relay device to be used with the Vista Solution and VitalPatch biosensor.
2018-02-20