Home GUDID 10817625020187
BLUE HAND
Primary DI 10817625020187
Brand BLUE HAND
Company BIOPROTECH INC.
Model 22SQ FO
Device description 2"x2" sq., Foam Top Electrodes, 1 pouch(2 pairs per pouch)
Published 2024-12-17
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name GXY Electrode, Cutaneous
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GXY Electrode, Cutaneous Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10817625020187 Package GS1 10 In Commercial Distribution 20817625020184 Package GS1 10 In Commercial Distribution 30817625020181 Package GS1 5 In Commercial Distribution 00817625020180 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10817625020187 10817625020187 20817625020184 20817625020184 30817625020181 30817625020181 00817625020180 00817625020180 817625020180 0817625020180
GMDN Terms# Term, Definition table Term Definition Transcutaneous electrical stimulation electrode, single-use An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 Degrees Celsius 40 Degrees Celsius
Regulatory Flags# DUNS number 688460539 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 08809083949129 TELECTRODE T817 2026-04-30 08809083949136 TELECTRODE T817A 2026-04-30 00858563006256 MAX-IF IF4000 2025-10-13 08809083946883 PROPLATE 9572C 2025-05-20 18809083946880 PROPLATE 9572C 2025-05-20 00815842021386 IMCO 2030-IMC 2025-05-16 10815842021383 IMCO 2030-IMC 2025-05-16 00851255007043 Dynamic DIAGNOSTICS, INC PEN11 2025-03-12 00851255007098 Dynamic DIAGNOSTICS, INC PEN31 2025-03-12 00851255007104 Dynamic DIAGNOSTICS, INC PEN21 2025-03-12 00851255007111 Dynamic DIAGNOSTICS, INC PEN41 2025-03-12 00851255007128 Dynamic DIAGNOSTICS, INC P9551F 2025-03-12 00851255007135 Dynamic DIAGNOSTICS, INC P9552F 2025-03-12 00851255007142 Dynamic DIAGNOSTICS, INC 9551F 2025-03-12 00851255007159 Dynamic DIAGNOSTICS, INC 9552F 2025-03-12 00851255007166 Dynamic DIAGNOSTICS, INC P9551-RF 2025-03-12 20851255007047 Dynamic DIAGNOSTICS, INC PEN11 2025-03-12 00851255007050 Dynamic DIAGNOSTICS, INC PEN11NS 2025-03-12 00851255007067 Dynamic DIAGNOSTICS, INC PEN31NS 2025-03-12 00851255007074 Dynamic DIAGNOSTICS, INC PEN21NS 2025-03-12
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