BIO PROTECH USA, INC.

Address:13620 Benson Ave,Chino,CA,91710,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

Electrode, Electrocardiograph (DRX) (9) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (1)

Premarket Exempt

No Yes

Clear

Bio Protech - 00817120020142 Catalog Number :

Device Description : T716C-50: TElectrode, 43mm x 45mm Oval, PE Foam, Carbon Snap, Radiotranslucent, T716C-50: TElectrode, 43mm x 45mm Oval, PE Foam, Carbon Snap, Radiotranslucent, General, 50pcs/pouch, 20 pouches/box, 1,000 pcs per Master Case

Device Class :

Duns Number: 789127011

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020159 Catalog Number :

Device Description : T718-50: TElectrode, 32mm x 38mm, PE Foam, Oval, Pediatric, Monitoring, 50/pouch T718-50: TElectrode, 32mm x 38mm, PE Foam, Oval, Pediatric, Monitoring, 50/pouch; 20pouch/Box; 1000pcs/master case

Device Class :

Duns Number: 789127011

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020166 Catalog Number :

Device Description : T815-5: TElectrode, Cloth, 55 mm Round, Stress & Holter, 5/pouch; 20pouch/Box; 1 T815-5: TElectrode, Cloth, 55 mm Round, Stress & Holter, 5/pouch; 20pouch/Box; 1000pcs/master case

Device Class :

Duns Number: 789127011

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020173 Catalog Number :

Device Description : T815-50: TElectrode, Cloth, 55 mm Round, Stress & Holter, 50/pouch; 20pouch/Box; T815-50: TElectrode, Cloth, 55 mm Round, Stress & Holter, 50/pouch; 20pouch/Box; 1000pcs/master case

Device Class :

Duns Number: 789127011

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020180 Catalog Number :

Device Description : T816-30: TElectrode, 43mm x 45mm, Cloth, Stress & Holter, Oval, 30/pouch; 20pouc T816-30: TElectrode, 43mm x 45mm, Cloth, Stress & Holter, Oval, 30/pouch; 20pouch/Box; 600pcs/Master case

Device Class :

Duns Number: 789127011

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020197 Catalog Number :

Device Description : T816-50: TElectrode, Oval, 43mm x 45mm, Cloth, Stress and Holter, 50/pouch; 20 p T816-50: TElectrode, Oval, 43mm x 45mm, Cloth, Stress and Holter, 50/pouch; 20 pouch/box; 1,000 pcs/master case

Device Class :

Duns Number: 789127011

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020203 Catalog Number :

Device Description : T832C-30: TElectrode, 32 mm Oval, Cloth, Full Gel, Carbon Snap, General, 30/pouc T832C-30: TElectrode, 32 mm Oval, Cloth, Full Gel, Carbon Snap, General, 30/pouch; 20pouch/Box; 600pcs/master case

Device Class :

Duns Number: 789127011

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020210 Catalog Number :

Device Description : T916-50: TElectrode, 43mm x 45mm, Clear Tape, Oval, General, 50/pouch; 20pouch/B T916-50: TElectrode, 43mm x 45mm, Clear Tape, Oval, General, 50/pouch; 20pouch/Box; 1000pcs/master case

Device Class :

Duns Number: 789127011

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020227 Catalog Number :

Device Description : T916C-50: TElectrode, 43mm x 45mm, Clear Tape, Carbon Snap, Radiolucent, Oval, G T916C-50: TElectrode, 43mm x 45mm, Clear Tape, Carbon Snap, Radiolucent, Oval, General, 50/pouch; 20pouch/Box; 1000pcs/master case

Device Class :

Duns Number: 789127011

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020234 Catalog Number :

Device Description : Pro-Pencil SB: SB- Slim, Hand Control, Button Switch, General Blade, Sterile, 1pc/pouch

Device Class : 2

Duns Number: 789127011

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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