Bio Protech

GUDID 00817120020128

T716-5: TElectrode, 43mm x 45mm Oval, PE Foam, General, Stress & Holter, 5 pc/pouch, 20 pouches/box, 10 boxes/ case, 1,000 pcs per master case

BIO PROTECH USA, INC.

Electrocardiographic electrode, single-use
Primary Device ID00817120020128
NIH Device Record Keycc946dcc-f0db-4305-8e6e-21ace0d0d22d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBio Protech
Version Model NumberT716-5
Company DUNS789127011
Company NameBIO PROTECH USA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone714-730-9950
Emailbioprotechusa@gmail.com
Phone714-730-9950
Emailbioprotechusa@gmail.com
Phone714-730-9950
Emailbioprotechusa@gmail.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817120020128 [Primary]
GS110817120020125 [Package]
Package: Inner Box [20 Units]
In Commercial Distribution
GS120817120020122 [Package]
Contains: 10817120020125
Package: Master Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRXElectrode, Electrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-29

On-Brand Devices [Bio Protech]

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30817120021409HiDow Rectangular Shape Tens Electrodes (2x3in BP Gel)- 2 pcs per pack/pouch, Multi use self-ad
30817120021393HiDow Palm Shape Tens Electrodes (2x3in Blue Gel) - 2 pcs per pack/pouch, Multi use self-adhesiv
30817120021386HiDow Palm Shape Tens Electrodes (2x3in BP Gel) - 2 pcs per pack/pouch, Multi use self-adhesive
308171200213794141WCBZ (ECO)- Econotens, 30mil gel, 41x41mm Square Electrode, White Fabric, Carbon, Plastic Zi
10817120021368RMC80 (Lifelines) - Lifelines OEM, Cables for Needle Electrodes, 80cm length, 1.5mm (DIN 42 802)
10817120021351RCC200 (Lifelines) - Lifelines OEM, Cables for Needle Electrodes, 2m length, 5 Pole DIN, 1 per p
20817120021341BCS-15 (Lifelines) - Lifelines OEM, Corkscrew needle, 150cm wire length, 1.5mm female TP connect
20817120021334BE1227P-15T (Lifelines) - Lifelines OEM, Twisted EP Needle, Pairs - 150cm Leadwire, 12mm length,
20817120021327BE1227P-25 (Lifelines) - Lifelines OEM, Subdermal EP Needle, 12mm length, 0.40mm diameter, 250cm
20817120021310BE1227P-20 (Lifelines) - Lifelines OEM, Subdermal EP Needle, 12mm length, 0.40mm diameter, 200cm
20817120021303BE1227P-15 (Lifelines) - Lifelines OEM, Subdermal EP Needle, 12mm length, 0.40mm diameter, 150cm
20817120021297BE1227P-10 (Lifelines) - Lifelines OEM, Subdermal EP Needle, 12mm length, 0.40mm diameter, 100cm
20817120021280BE1227P-05 (Lifelines) - Lifelines OEM, Subdermal EP Needle, 12mm length, 0.40mm diameter, 50cm
308171200212704141WCBZGN (ECO)- Econotens, 30mil gel, 41x41mm Square Electrode, White Fabric, Carbon, Plastic
20817120021266RSEEG-20 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 2.0m Length, Silver plated copper fibe
20817120021259RSEEG-15 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.5m Length, Silver plated copper fibe
20817120021242RSEEG-12 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.2m Length, Silver plated copper fibe
20817120021235RSEEG-10 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.0m Length, Silver plated copper fibe
20817120021228RSEEG-05 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 0.5m Length, Silver plated copper fibe
20817120021211RGEEG-20 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 2.0m Length, Silver plated copper fibe
20817120021204RGEEG-15 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.5m Length, Silver plated copper fibe
20817120021198RGEEG-12 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.2m Length, Silver plated copper fibe
20817120021181RGEEG-10 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.0m Length, Silver plated copper fibe
20817120021174RGEEG-05 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 0.5m Length, Silver plated copper fibe
20817120021167DEEG-A-20 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 2.0m Length, Cooper Fiber + PVC Sheat
20817120021150DEEG-A-15 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.5m Length, Cooper Fiber + PVC Sheat
20817120021143DEEG-A-12 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.2m Length, Cooper Fiber + PVC Sheat
20817120021136DEEG-A-10 (Lifelines) - Lifelines OEM, EEG Cup Electrodes, 1.0m Length, Cooper Fiber + PVC Sheat
00817120021125MF2409 (Lifelines) - Lifelines OEM, Surface Electrodes, Ring Electrode, PET Film Backing Materia
00817120021118NCS-SG15 (Lifelines) - Lifelines OEM, Surface Electrodes, Trio Electrode, Round Shape, Cloth Ba
00817120021101NCS-1334 (Lifelines) - Lifelines OEM, Surface Electrodes, NCS Surface Electrode, Tabs, PET Film
00817120021095SG15G (Lifelines) - Lifelines OEM, Surface Electrodes, Square Shape, Ground Electrode, Cloth Bac
20817120021082SG15R (Lifelines) - Lifelines OEM, Surface Electrodes, 4-Disk, Cloth Backing, Dia 19mm, Hydrogel
10817120021078RNC100 (Lifelines) - Lifelines OEM, Cables for Surface Electrodes, 1.5m length, 1.5mm (DIN 42 80
10817120021061RMC100 (Lifelines) - Lifelines OEM, Cables for Needle Electrodes, 1m length, 1.5mm (DIN 42 802),
10817120021054RCC100 (Lifelines) - Lifelines OEM, Cables for Needle Electrodes, 1m length, 5 Pole DIN, 1 per p
20817120021044BH7523P (Lifelines) - Lifelines OEM, Pre-wired Hypodermics needle, 75mm length, 0.65mm(23G) Diam
20817120021037BH5026P (Lifelines) - Lifelines OEM, Pre-wired Hypodermics needle, 50mm length, 0.45mm(26G) Diam
20817120021020BH3726P (Lifelines) - Lifelines OEM, Pre-wired Hypodermics needle, 37mm length, 0.45mm(26G) Diam
20817120021013BH3727P (Lifelines) - Lifelines OEM, Pre-wired Hypodermics needle, 37mm length, 0.40mm(27G) Diam
20817120021006BH2527P (Lifelines) - Lifelines OEM, Pre-wired Hypodermics needle, 25mm length, 0.40mm(27G) Diam
20817120020993BH2530P (Lifelines) - Lifelines OEM, Pre-wired Hypodermics needle, 25mm length, 0.30mm(30G) Diam
20817120020986BM7526P (Lifelines) - Lifelines OEM, Pre-wired Monopolar needle, 75mm length, 0.45mm (26G) Diame
20817120020979BM7526 (Lifelines) - Lifelines OEM, Non-wired Monopolar needle, 75mm length, 0.45mm (26G) Diamet
20817120020962BM5026P (Lifelines) - Lifelines OEM, Pre-wired Monopolar needle, 50mm length, 0.45mm (26G) Diame
20817120020955BM5026(Lifelines) - Lifelines OEM, Non-wired Monopolar needle, 50mm length, 0.45mm (26G) Diamete
20817120020948BM3726P (Lifelines) - Lifelines OEM, Pre-wired Monopolar needle, 37mm length, 0.45mm (26G) Diame
20817120020931BM3726 (Lifelines) - Lifelines OEM, Non-wired Monopolar needle, 37mm length, 0.45mm (26G) Diamet
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