PREVENTICE TECHNOLOGIES, INC.

Address:2900 37th Street NW, Building 003,ROCHESTER,MN,55901,US

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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

Detector And Alarm, Arrhythmia (DSI) (7) Electrode, Electrocardiograph (DRX) (2)

Premarket Exempt

No Yes

Clear

BodyGuardian Mini Monitoring System Kit - 00852132007217 Catalog Number :

Device Description : BodyGuardian Mini Monitoring System Kit - holter for FBS customers

Device Class : 2

Duns Number: 859807815

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

BodyGuardian Mini Plus Monitoring System Kit - 00852132007224 Catalog Number :

Device Description : BodyGuardian Mini Plus Monitoring System Kit for FBS customers

Device Class : 2

Duns Number: 859807815

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

BodyGuardian Mini Short Slide Strip - 00852132007231 Catalog Number : SP2006

Device Description : Mini Short Slide Strip - Acrylic

Device Class : 2

Duns Number: 859807815

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

BodyGuardian One - 00852132007248 Catalog Number :

Device Description : BodyGuardian One FBS Remote Monitoring System

Device Class : 2

Duns Number: 859807815

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

BodyGuardian - 00852132007255 Catalog Number : SP2007

Device Description : Mini Short Slide Strip - Hydrocolloid

Device Class : 2

Duns Number: 859807815

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

PatientCare Platform - 00852132007286 Catalog Number :

Device Description : Platform software application for data collection and analysis

Device Class : 2

Duns Number: 859807815

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

BodyGuardian Connect - 00852132007293 Catalog Number :

Device Description : Transmission software application

Device Class : 2

Duns Number: 859807815

Premarket Exempt : Yes

Product Code : DSI

Prescription Use : Yes

Device Count : 1

ECG Plug-In - 00852132007309 Catalog Number :

Device Description : Monitor communication software application

Device Class : 2

Duns Number: 859807815

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

PatientCare Link - 00852132007316 Catalog Number :

Device Description : Upload and transmission software application

Device Class : 2

Duns Number: 859807815

Premarket Exempt : Yes

Product Code : DSI

Prescription Use : Yes

Device Count : 1

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