BIO PROTECH, INC.

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• EvaQMax Smoke Evacuation System

  2019-08-29

  Bio Protech, Inc.

• Disposable Concentric Needle Electrodes, Disposable Monopolar Needle Electrodes, Disposable EP Needle Electrodes, Disposable Hypodermic Needle Electrodes

  2016-06-03

  BIO PROTECH, INC.

• Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes

  2016-03-21

  BIO PROTECH, INC.

• PROPENCIL Smoke Pencil

  2015-07-16

  BIO PROTECH, INC.

• CUTANEOUS ELECTRODES

  2014-11-17

  BIO PROTECH, INC.

• REUSABLE STIMULATING ELECTRODES

  2011-09-13

  BIO PROTECH, INC.

• MAX-IF1000

  2010-11-24

  BIO PROTECH, INC.

• MAXEMS, MODELS 1000 AND 2000

  2009-11-30

  BIO PROTECH, INC.

• PROPENCIL ESU PENCIL

  2009-11-25

  BIO PROTECH, INC.

• PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C

  2009-11-24

  BIO PROTECH, INC.

• TELECTRODE WET GEL ECG ELECTRODE

  2008-11-07

  BIO PROTECH, INC.

• PROSTIM 1000/2000

  2008-02-07

  BIO PROTECH, INC.

• PROPLATE

  2007-12-19

  BIO PROTECH, INC.

• PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20

  2005-12-14

  BIO PROTECH, INC.

• PROTENS ELECTRODE

  2004-09-03

  BIO PROTECH, INC.

• PROTAB ECG TABB ELECTRODE

  2004-04-07

  BIO PROTECH, INC.

• ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE

  2002-11-07

  BIO PROTECH, INC.

GUDID#

• BLUE HAND - 1.5"x1.5" sq., cloth, 1 pouch(2 pairs per pouch)

  BIO PROTECH USA, INC.

  2026-07-07

• BLUE HAND - 3" round, foam, 1 pouch(2 pcs per pouch)

  BIO PROTECH USA, INC.

  2026-07-07

• BLUE HAND - 2"x4" rect., foam, 1 pouch(2 pcs per pouch)

  BIO PROTECH USA, INC.

  2026-07-07

• BLUE HAND - 2"x2" sq., foam, 1 pouch(2 pairs per pouch)

  BIO PROTECH USA, INC.

  2026-07-07

• BLUE HAND - 2" round, foam, 1 pouch(2 pairs per pouch)

  BIO PROTECH USA, INC.

  2026-07-07

• BLUE HAND - 1.5" round, foam, 1 pouch(2 pairs per pouch)

  BIO PROTECH USA, INC.

  2026-07-07

• BLUE HAND - 1.5"x1.5" sq., foam, 1 pouch(2 pairs per pouch)

  BIO PROTECH USA, INC.

  2026-07-07

• BLUE HAND - 3" round, cloth, 1 pouch(2 pcs per pouch)

  BIO PROTECH USA, INC.

  2026-07-07

• Bio Protech - Generic (4848WCBZGN (48x48 sq. white cloth, NSCNS 35mil), 40pcs/PKG (no zipper)

  BIO PROTECH USA, INC.

  2026-05-07

• Bio Protech - 4848WCBZGN(NST) - 48mmx48mm Square Electrodes, White Fabric, Carbon, Plastic Zip Lock

  BIO PROTECH USA, INC.

  2016-06-21

• Bio Protech - Generic (4848WCBZGN (48x48 sq. white cloth, NSCNS 35mil), 20 pcs/1 poly, No zipper

  BIO PROTECH USA, INC.

  2016-06-15

• Bio Protech - MF2409 (Lifelines) - Lifelines OEM, Surface Electrodes, Ring Electrode, PET Film Backing Material, 8x107mm, Hydrogel, 10 pcs per pack, 100 pcs per box, 1,000 pcs per case

  BIO PROTECH USA, INC.

  2017-08-09

• Bio Protech - NCS-SG15 (Lifelines) - Lifelines OEM, Surface Electrodes, Trio Electrode, Round Shape, Cloth Backing Material, 22x22mm, Hydrogel, 3 pcs per pack, 75 pcs per box, 750 pcs per case

  BIO PROTECH USA, INC.

  2017-08-09

• Bio Protech - NCS-1334 (Lifelines) - Lifelines OEM, Surface Electrodes, NCS Surface Electrode, Tabs, PET Film Backing Material, 13x24mm, Hydrogel, 100 pcs per pack, 500 pcs per box, 5,000 pcs per case

  BIO PROTECH USA, INC.

  2017-08-09

• Bio Protech - SG15G (Lifelines) - Lifelines OEM, Surface Electrodes, Square Shape, Ground Electrode, Cloth Backing, 42x60mm, Hydrogel. 1pc per pack, 25 pcs per box, 250 pcs per case

  BIO PROTECH USA, INC.

  2017-08-09

• Bio Protech - SG15R (Lifelines) - Lifelines OEM, Surface Electrodes, 4-Disk, Cloth Backing, Dia 19mm, Hydrogel. 4 pcs per pack, 100 pcs per box, 1,000 pcs per case

  BIO PROTECH USA, INC.

  2017-08-09

• Bio Protech - MaxTens 2k - Digital Tens Unit

  BIO PROTECH USA, INC.

  2016-06-16

• Bio Protech - MaxTens 1k - Analog Tens Unit, with Black Carrying Case

  BIO PROTECH USA, INC.

  2016-09-01

• Bio Protech - MaxEMS 2k - Digital EMS Unit

  BIO PROTECH USA, INC.

  2016-06-17

• Bio Protech - MaxEMS 1k - Analog EMS Unit

  BIO PROTECH USA, INC.

  2016-06-16

• Bio Protech - MaxTens 1k - Analog Tens Unit

  BIO PROTECH USA, INC.

  2016-06-15

• Bio Protech - RSEEG-20 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 2.0m Length, Silver plated copper fiber + PTFE or Silicon Sheath, 92.5% Silver, Reusable EEG Cups

  BIO PROTECH USA, INC.

  2017-08-09

• Bio Protech - RSEEG-15 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.5m Length, Silver plated copper fiber + PTFE or Silicon Sheath, 92.5% Silver, Reusable EEG Cups

  BIO PROTECH USA, INC.

  2017-08-09

• Bio Protech - RSEEG-12 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.2m Length, Silver plated copper fiber + PTFE or Silicon Sheath, 92.5% Silver, Reusable EEG Cups

  BIO PROTECH USA, INC.

  2017-08-09

• Bio Protech - RSEEG-10 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.0m Length, Silver plated copper fiber + PTFE or Silicon Sheath, 92.5% Silver, Reusable EEG Cups

  BIO PROTECH USA, INC.

  2017-08-09

• Bio Protech - RSEEG-05 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 0.5m Length, Silver plated copper fiber + PTFE or Silicon Sheath, 92.5% Silver, Reusable EEG Cups

  BIO PROTECH USA, INC.

  2017-08-09

• Bio Protech - RGEEG-20 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 2.0m Length, Silver plated copper fiber + PTFE or Silicon Sheath, Gold Plated 92.5% Silver, Reusable EEG Cups

  BIO PROTECH USA, INC.

  2017-08-09

• Bio Protech - RGEEG-15 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.5m Length, Silver plated copper fiber + PTFE or Silicon Sheath, Gold Plated 92.5% Silver, Reusable EEG Cups

  BIO PROTECH USA, INC.

  2017-08-09

• Bio Protech - RGEEG-12 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.2m Length, Silver plated copper fiber + PTFE or Silicon Sheath, Gold Plated 92.5% Silver, Reusable EEG Cups

  BIO PROTECH USA, INC.

  2017-08-09

• Bio Protech - RGEEG-10 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.0m Length, Silver plated copper fiber + PTFE or Silicon Sheath, Gold Plated 92.5% Silver, Reusable EEG Cups

  BIO PROTECH USA, INC.

  2017-08-09

• Bio Protech - RGEEG-05 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 0.5m Length, Silver plated copper fiber + PTFE or Silicon Sheath, Gold Plated 92.5% Silver, Reusable EEG Cups

  BIO PROTECH USA, INC.

  2017-08-09

• Bio Protech - DEEG-A-20 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 2.0m Length, Cooper Fiber + PVC Sheath, Ag/AgCI plated Plastic, Single Use

  BIO PROTECH USA, INC.

  2017-08-09

• Bio Protech - DEEG-A-15 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.5m Length, Cooper Fiber + PVC Sheath, Ag/AgCI plated Plastic, Single Use

  BIO PROTECH USA, INC.

  2017-08-09

• Bio Protech - DEEG-A-12 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.2m Length, Cooper Fiber + PVC Sheath, Ag/AgCI plated Plastic, Single Use

  BIO PROTECH USA, INC.

  2017-08-09

• Bio Protech - DEEG-A-10 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.0m Length, Cooper Fiber + PVC Sheath, Ag/AgCI plated Plastic, Single Use

  BIO PROTECH USA, INC.

  2017-08-09

• Bio Protech - P9552F - Grounding Pads, Corded, Adult, Foam, Dual Pad, Horizontal (1pc per pouch, 25pc per box, 8box per case)

  BIO PROTECH USA, INC.

  2017-06-06

• Bio Protech - Saebo TENS Small Electrode (3pc/Pouch) - Each

  BIO PROTECH USA, INC.

  2021-04-06

• Bio Protech - Saebo TENS Large Electrode (3pc/Pouch) - Each

  BIO PROTECH USA, INC.

  2021-04-06

• Bio Protech - RG07WCBZ(NST)- 80mmx40mm Rectangle Electrodes, White Fabric, Carbon, Plastic Zip Lock

  BIO PROTECH USA, INC.

  2016-06-23

• Bio Protech - RG02FCBZGN(NST) - 90mmx50mm Rectangle Electrodes, Foam, Carbon, Plastic Zip Lock

  BIO PROTECH USA, INC.

  2016-06-22

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