Home GUDID B311PEPADBFLY1 PURE ENRICHMENT
Primary DI B311PEPADBFLY1
Brand PURE ENRICHMENT
Company BEAR DOWN CONSULTING
Model PEPADBFLY
Device description LARGE ELECTRODE PAD
Published 2016-10-19
Public version status Update
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 B311PEPADBFLY1 Package HIBCC 350 In Commercial Distribution B311PEPADBFLY2 Package HIBCC 250 In Commercial Distribution B311PEPADBFLY3 Package HIBCC 2 In Commercial Distribution B311PEPADBFLY0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Transcutaneous electrical stimulation electrode A non-sterile 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, 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-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.
Regulatory Flags# DUNS number 040869867 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00817717023105 SENSADERM Vision Quest Industries Incorporated GXY 2026-10-23 00817717023112 SENSADERM Vision Quest Industries Incorporated GXY 2026-10-23 00817717023129 SENSADERM BLUE Vision Quest Industries Incorporated GXY 2026-10-23 00817717023136 SENSADERM Vision Quest Industries Incorporated GXY 2026-10-23 00851913006296 UltraStim Wire Foam AXELGAARD MANUFACTURING CO., LTD. GXY 2026-10-21 00382830063821 Natus XLTEK GXY 2026-10-15 00382830063838 Natus XLTEK GXY 2026-10-15 00382830063845 Natus XLTEK GXY 2026-10-15 00382830063852 Natus XLTEK GXY 2026-10-15 00382830063869 Natus XLTEK GXY 2026-10-15 00382830063876 Natus XLTEK GXY 2026-10-15 00382830063883 Natus XLTEK GXY 2026-10-15 00382830063890 Natus XLTEK GXY 2026-10-15 00382830063906 Natus XLTEK GXY 2026-10-15 00382830063913 Natus XLTEK GXY 2026-10-15 00382830063920 Natus XLTEK GXY 2026-10-15 00382830063937 Natus XLTEK GXY 2026-10-15 06973602731105 Premium Gel White Fabri Electrodes TOP-RANK HEALTH CARE CO., LTD. GXY 2026-10-12 06973602731112 Premium Gel White Fabri Electrodes TOP-RANK HEALTH CARE CO., LTD. GXY 2026-10-12 06973602731129 Premium Gel White Fabri Electrodes TOP-RANK HEALTH CARE CO., LTD. GXY 2026-10-12 00850080988718 AUVON UAN HEALTHCARE LIMITED GXY 2026-10-08 00810200390265 KS K.S. CHOI, CORPORATION GXY 2026-09-22 00810200390272 AcuZone K.S. CHOI, CORPORATION GXY 2026-09-22 00860014334320 PASCALL SYSTEMS, INC. PASCALL SYSTEMS, INC. GXY 2026-09-04 08720791379131 EZ1020 Technomed Engineering B.V. GXY 2026-08-07 08720791379148 EZ1020 Technomed Engineering B.V. GXY 2026-08-07 08720791379155 EZ1020 Technomed Engineering B.V. GXY 2026-08-07 08720791379162 EZ1020 Technomed Engineering B.V. GXY 2026-08-07 08720791379179 EZ1020 Technomed Engineering B.V. GXY 2026-08-07 08720791379209 EZ1020 Technomed Engineering B.V. GXY 2026-08-07
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