Vital Connect, Inc.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Transmitters And Receivers, Physiological Signal, Radiofrequency (DRG) (10) Detector And Alarm, Arrhythmia (DSI) (7) Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (MHX) (7)

Premarket Exempt

No Yes

Clear

HealthPatch® MD Gentle Patch - 00850490007009 Catalog Number :

Device Class : 2

Duns Number: 944642730

Premarket Exempt : No

Product Code : MHX, DSI, DRG

Prescription Use : Yes

Device Count : 1

HealthPatch® MD Active Patch - 00850490007016 Catalog Number :

Device Class :

Duns Number: 944642730

Premarket Exempt : No

Product Code : MHX, DSI, DRG

Prescription Use : Yes

Device Count : 1

HealthPatch® MD Module - 00850490007047 Catalog Number :

Device Class :

Duns Number: 944642730

Premarket Exempt : No

Product Code : MHX, DSI, DRG

Prescription Use : Yes

Device Count : 1

"VitalPatch™ Gentle Patch - 00850490007054 Catalog Number :

Device Class : 2

Duns Number: 944642730

Premarket Exempt : No

Product Code : MHX, DSI, DRG

Prescription Use : Yes

Device Count : 1

"VitalPatch™ Active Patch - 00850490007078 Catalog Number :

Device Class : 2

Duns Number: 944642730

Premarket Exempt : No

Product Code : MHX, DSI, DRG

Prescription Use : Yes

Device Count : 1

VistaCenter - 00850490007139 Catalog Number : 6200-01

Device Description : Multipatient user interface, convenience view of VistaPoint

Device Class : 2

Duns Number: 944642730

Premarket Exempt : No

Product Code : DRG

Prescription Use : Yes

Device Count : 1

VitalPatch® Active Biosensor - 00850490007146 Catalog Number :

Device Class :

Duns Number: 944642730

Premarket Exempt : No

Product Code : MHX, DSI, DRG

Prescription Use : Yes

Device Count : 1

VistaPoint Software User Interface - 00850490007160 Catalog Number : 6100-01

Device Description : User interface in the patient's room

Device Class : 2

Duns Number: 944642730

Premarket Exempt : No

Product Code : DRG

Prescription Use : Yes

Device Count : 1

VistaHub-WiFi - 00850490007177 Catalog Number : 8001-01

Device Description : VistaHub-WiFi relay device to be used with the Vista Solution and VitalPatch biosensor.

Device Class : 2

Duns Number: 944642730

Premarket Exempt : No

Product Code : MHX, DSI, DRG

Prescription Use : Yes

Device Count : 1

VistaTablet - 00850490007207 Catalog Number : 8101-01

Device Description : VistaTablet is a tablet which will be running the VistaPoint software user inter VistaTablet is a tablet which will be running the VistaPoint software user interface in a Web container

Device Class :

Duns Number: 944642730

Premarket Exempt : No

Product Code : DRG

Prescription Use : Yes

Device Count : 1

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