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 - 08809083941567 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

CareFusion - 08809083941574 Catalog Number :

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

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Vyaire - 08809083941581 Catalog Number :

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

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

CareFusion - 08809083941598 Catalog Number :

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

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Vyaire - 08809083941604 Catalog Number :

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

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

CareFusion - 08809083941611 Catalog Number :

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

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Vyaire - 08809083941628 Catalog Number :

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

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

CareFusion - 08809083941635 Catalog Number :

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

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Vyaire - 08809083941642 Catalog Number :

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

Device Class : 2

Duns Number: 688460539

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

CareFusion - 08809083941659 Catalog Number :

Device Description : ELECTRODE, ADULT, CLEAR TAPE, ROUND, SOLID 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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