VECTRACOR INC

Address:6901 E. Fish Lake Road,Maple Grove,MN,55369,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

Electrocardiograph (DPS) (3) Clip, Nose (BXJ) (2) Monitor, St Segment With Alarm (MLD) (2) Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (MHX) (1) System,Network And Communication,Physiological Monitors (MSX) (1) Mouthpiece, Breathing (BYP) (1) Shave Prep Kit (OJW) (1) Spirometer, Diagnostic (BZG) (1) Electrode, Electrocardiograph (DRX) (1)

Premarket Exempt

No Yes

Clear

Vectraplex CMS - 00857175006012 Catalog Number :

Device Description : Vectraplex Central Monitoring System

Device Class : 2

Duns Number: 828416359

Premarket Exempt : No

Product Code : MHX, MLD, MSX

Prescription Use : Yes

Device Count : 1

VectraplexECG System - 00857175006029 Catalog Number :

Device Description : VectraplexECG System with Cardio Electrical Bio-marker (CEB)

Device Class : 2

Duns Number: 828416359

Premarket Exempt : No

Product Code : DPS, MLD

Prescription Use : Yes

Device Count : 1

Universal ECG - 00857175006043 Catalog Number : Z-7000-0301

Device Description : ECG Amplifier

Device Class : 2

Duns Number: 828416359

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Orbit Spirometer - 00857175006050 Catalog Number : Z-7000-0101

Device Description : Orbit Spirometer

Device Class : 2

Duns Number: 828416359

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

Holter Prep Kit - 00857175006111 Catalog Number :

Device Description : Holter prep kitEach prep kit contains:1 razor1 alcohol pad1 AA battery1 skin scr Holter prep kitEach prep kit contains:1 razor1 alcohol pad1 AA battery1 skin scrubby1 page of 5 wet gel electrodes1 patient diary

Device Class :

Duns Number: 828416359

Premarket Exempt : Yes

Product Code : OJW

Prescription Use : Yes

Device Count : 25

Office Medic - 00857175006166 Catalog Number :

Device Description : Office Medic Software

Device Class : 2

Duns Number: 828416359

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Plastic Mouthpieces (100) - 10857175006071 Catalog Number :

Device Description : Plastic Mouthpieces box of 100

Device Class :

Duns Number: 828416359

Premarket Exempt : Yes

Product Code : BYP

Prescription Use : Yes

Device Count : 100

Nose Clips - 10857175006088 Catalog Number :

Device Class :

Duns Number: 828416359

Premarket Exempt : Yes

Product Code : BXJ

Prescription Use : No

Device Count : 50

Wet Gel Monitoring Electrodes - 10857175006132 Catalog Number :

Device Description : Wet Gel Electrodes Inner Pack of 5

Device Class :

Duns Number: 828416359

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 5

Nose Clips - 20857175006085 Catalog Number :

Device Description : Nose Clips

Device Class :

Duns Number: 828416359

Premarket Exempt : Yes

Product Code : BXJ

Prescription Use : No

Device Count : 5

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