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 - 08809083941468 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

CareFusion - 08809083941475 Catalog Number :

Device Description : ELECTRODE, ADULT, FOAM, ROUND, SOLID GEL, 3/STRIP

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Vyaire - 08809083941482 Catalog Number :

Device Description : ELECTRODE, ADULT, FOAM, ROUND, SOLID GEL, 3/STRIP

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

CareFusion - 08809083941499 Catalog Number :

Device Description : ELECTRODE, ADULT, FOAM, ROUND, SOLID GEL, 5/STRIP

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Vyaire - 08809083941505 Catalog Number :

Device Description : ELECTRODE, ADULT, FOAM, ROUND, SOLID GEL, 5/STRIP

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

CareFusion - 08809083941512 Catalog Number :

Device Description : ELECTRODE, ADULT, FOAM, ROUND, SOLID GEL, 50/POUCH

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Vyaire - 08809083941529 Catalog Number :

Device Description : ELECTRODE, ADULT, FOAM, ROUND, SOLID GEL, 50/POUCH

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

CareFusion - 08809083941536 Catalog Number :

Device Description : ELECTRODE, PEDIATRIC, FOAM, ROUND, SOLID GEL, 50/POUCH

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Vyaire - 08809083941543 Catalog Number :

Device Description : ELECTRODE, PEDIATRIC, FOAM, ROUND, SOLID GEL, 50/POUCH

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

CareFusion - 08809083941550 Catalog Number :

Device Description : ELECTRODE, ADULT, FOAM, ROUND, WET GEL, 50/POUCH

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

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