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, Cutaneous (GXY) (6) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (2) Cable, Electrode (IKD) (1) Electrode, Electrocardiograph (DRX) (1)

Premarket Exempt

No Yes

Clear

Bio Protech - 00817120020449 Catalog Number :

Device Description : RG07WCBZ(NST)- 80mmx40mm Rectangle Electrodes, White Fabric, Carbon, Plastic Zip Lock

Device Class :

Duns Number: 789127011

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020456 Catalog Number :

Device Description : LWSBR48(N)- Leadwires, 2 sets, 48'' long, Safety Plug, Black and Red Coloring, 5 LWSBR48(N)- Leadwires, 2 sets, 48'' long, Safety Plug, Black and Red Coloring, 500 sets/ in a case

Device Class :

Duns Number: 789127011

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020470 Catalog Number :

Device Description : P9551F- Grounding Pad, Corded, Foam, Adult, Single, Horizontal (DO NOT USE)

Device Class :

Duns Number: 789127011

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020487 Catalog Number :

Device Description : P9552F - Grounding Pads, Corded, Adult, Foam, Dual Pad, Horizontal (Do Not Use)

Device Class :

Duns Number: 789127011

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020494 Catalog Number :

Device Description : RG07FCTZ(NST) - 80x40mm Electrodes, White Foam Backing, Carbon, Plastic Zip Lock

Device Class : 2

Duns Number: 789127011

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020500 Catalog Number :

Device Description : 3838WCBZ (NST) - 38x38mm Electrodes, White Fabric, Carbon, Plastic Zip Lock

Device Class : 2

Duns Number: 789127011

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020517 Catalog Number :

Device Description : 3838FCTZ(NST) - 38x38mm Electrodes, Foam, Carbon, Plastic Zip Lock

Device Class : 2

Duns Number: 789127011

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020524 Catalog Number :

Device Description : 38RdWCTZ(NST) - 38mm Round Electrodes, White Fabric, Carbon, Plastic Zip Lock

Device Class : 2

Duns Number: 789127011

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020531 Catalog Number :

Device Description : 38RdFCTZ(NST) - 38mm Round Electrodes, Foam, Carbon, Plastic Zip Lock

Device Class : 2

Duns Number: 789127011

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Bio Protech - 00817120020548 Catalog Number :

Device Description : T713VT-50 ECG Electrode - PE Foam, 50mmx54mm Tear Drop Shape, Adult. Stress & Ho T713VT-50 ECG Electrode - PE Foam, 50mmx54mm Tear Drop Shape, Adult. Stress & Holter, 50/pouch, 20pouch/Box, 1000pcs per Master Case

Device Class :

Duns Number: 789127011

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

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