MORTARA INSTRUMENT, 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

Electrode, Electrocardiograph (DRX) (5) Computer, Diagnostic, Programmable (DQK) (1) Electrocardiograph (DPS) (1) Electrocardiograph,Ambulatory(Without Analysis) (MWJ) (1)

Premarket Exempt

Clear

Snap Adapter - 10812345023050 Catalog Number :

Device Description : ECG Adapter

Device Class :

Duns Number: 062046149

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 10

Quick-Trace Multi-purpose ECG electrodes - 10812345024231 Catalog Number :

Device Description : Electrodes

Device Class :

Duns Number: 062046149

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 30

CardioSens/Ultra II - 10812345024682 Catalog Number :

Device Description : Electrodes

Device Class :

Duns Number: 062046149

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 100

Resting Tab Type Electrodes - 10812345024729 Catalog Number :

Device Description : Electrodes

Device Class :

Duns Number: 062046149

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 100

ECG Monitoring Electrodes - 10812345024736 Catalog Number :

Device Description : Electrodes

Device Class :

Duns Number: 062046149

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 10

Quik-Prep - 10812345024743 Catalog Number :

Device Description : Electrodes

Device Class :

Duns Number: 062046149

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 5

Holter Prep Kit - 10812345026020 Catalog Number :

Device Description : Holter prep kit with AAA battery cleared with H3+ Holter recorder

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : MWJ

Prescription Use : Yes

Device Count : 1

Holter Prep Kit - 10812345029939 Catalog Number :

Device Description : Holter prep kit with AA battery cleared with Vision 5LR recorder

Device Class :

Duns Number: 062046149

Premarket Exempt : No

Product Code : DQK

Prescription Use : Yes

Device Count : 1

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