BIOPROTECH 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) (10)

Premarket Exempt

Clear

Vyaire - 08809083941338 Catalog Number :

Device Description : Adult Resting ECG Electrodes, Aggressive Adhesive

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

CareFusion - 08809083941352 Catalog Number :

Device Description : Adult Resting ECG Electrodes, Moderate Adhesive

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Vyaire - 08809083941369 Catalog Number :

Device Description : Adult Resting ECG Electrodes, Moderate Adhesive

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

CareFusion - 08809083941383 Catalog Number :

Device Description : Pediatric Resting ECG Electrodes, Mild Adhesive

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Vyaire - 08809083941390 Catalog Number :

Device Description : Pediatric Resting ECG Electrodes, Mild Adhesive

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

CareFusion - 08809083941413 Catalog Number :

Device Description : Radiolucent Neonatal Cloth Monitoring Electrodes w/Preattached Ldwrs

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Vyaire - 08809083941420 Catalog Number :

Device Description : Radiolucent Neonatal Cloth Monitoring Electrodes w/Preattached Ldwrs

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

CareFusion - 08809083941437 Catalog Number :

Device Description : Radiolucent Neonatal Cloth Monitoring Electrodes w/Preattached Lead wires (IEC v Radiolucent Neonatal Cloth Monitoring Electrodes w/Preattached Lead wires (IEC version colors lead wires)

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Vyaire - 08809083941444 Catalog Number :

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

CareFusion - 08809083941451 Catalog Number :

Device Description : Radiolucent Neonatal Cloth Monitoring Snap Electrodes

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

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