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) (6) Electrode, Electrocardiograph (DRX) (3) Electrode, Electrodcardiograph, Multi-Function (MLN) (1)

Premarket Exempt

No Yes

Clear

BodyGuardian - 00852132007101 Catalog Number : SP2003

Device Description : Mini Slide Strip - Acrylic

Device Class : 2

Duns Number: 859807815

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

BodyGuardian - 00852132007118 Catalog Number :

Device Description : BodyGuardian Mini Biobank kit

Device Class : 2

Duns Number: 859807815

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

BodyGuardian - 00852132007125 Catalog Number :

Device Description : BodyGuardian Mini Holter Monitoring System Kit

Device Class : 2

Duns Number: 859807815

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

BodyGuardian - 00852132007132 Catalog Number :

Device Description : BodyGuardian Mini Holter Monitoring System kit

Device Class : 2

Duns Number: 859807815

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

BodyGuardian - 00852132007149 Catalog Number :

Device Description : BodyGuardian Mini Plus Remote Monitoring System Kit

Device Class : 2

Duns Number: 859807815

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

BodyGuardian - 00852132007156 Catalog Number :

Device Description : BodyGuardian Mini Plus Procedure Pack

Device Class : 2

Duns Number: 859807815

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

BodyGuardian - 00852132007163 Catalog Number :

Device Description : BodyGuardian Mini Bridge

Device Class : 2

Duns Number: 859807815

Premarket Exempt : Yes

Product Code : MLN

Prescription Use : Yes

Device Count : 1

BodyGuardian - 00852132007187 Catalog Number : SP2004

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 Mini Short Slide Strip - 00852132007194 Catalog Number : SP2005

Device Description : Mini Short Slide Strip - Silicone

Device Class : 2

Duns Number: 859807815

Premarket Exempt : Yes

Product Code : DRX

Prescription Use : Yes

Device Count : 1

BodyGuardian - 00852132007200 Catalog Number :

Device Description : BodyGuardian Mini Procedure Pack

Device Class : 2

Duns Number: 859807815

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

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