Home GUDID 10073796636019
Omron Avail Wireless T.E.N.S.
Primary DI 10073796636019
Brand Omron Avail Wireless T.E.N.S.
Company Omron Healthcare, Inc.
Model PM601
Catalog number PM601
Device description Wireless, dual-channel electrotherapy unit.
Published 2017-12-15
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use false
Product Codes# Code, Name table Code Name NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10073796636019 Package GS1 6 In Commercial Distribution 00073796636012 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 10073796636019 10073796636019 00073796636012 00073796636012 073796636012 0073796636012
GMDN Terms# Term, Definition table Term Definition Analgesic transcutaneous electrical nerve stimulation system An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Handling Environment Humidity 30 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Handling Environment Temperature 10 Degrees Celsius 40 Degrees Celsius Handling Environment Temperature 50 Degrees Fahrenheit 104 Degrees Fahrenheit Storage Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature -20 Degrees Celsius 60 Degrees Celsius Storage Environment Temperature -4 Degrees Fahrenheit 140 Degrees Fahrenheit
Regulatory Flags# DUNS number 054318779 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true 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 00073796252601 Silver, Upper Arm Blood Pressure Monitor BP5260 2026-05-26 00073796451004 Omron MicroAir Vibrating Mesh Nebulizer NE-U100 NE-U100 2018-10-22 00073796800147 Omron CompAir Compressor Nebulizer RE-C800KD RE-C800KD 2020-08-03 00073796451226 Omron Micro Air Vibrating Mesh Nebulizer NE-U22V NE-U22V 2017-05-17 00073796453305 Omron CompAir Elite Compact Compressor Nebulizer NE-C30 NE-C30 2017-05-17 00073796458010 Omron CompAir Compressor Nebulizer NE-C801 NE-C801 2017-05-17 00073796458034 Omron CompAir Mini-Nebulizer NE-C803 NE-C803 2017-05-17 00073796760069 Upper Arm Blood Pressure Monitor HEM-7600T-CD6 HEM-7600T-CD6 2025-07-15 10073796760066 Upper Arm Blood Pressure Monitor HEM-7600T-CD6 HEM-7600T-CD6 2025-07-15 00073796736538 Blood Pressure Monitor BP7365CAN-CD6 BP7365CAN-CD6 2025-06-27 10073796736535 Blood Pressure Monitor BP7365CAN-CD6 BP7365CAN-CD6 2025-06-27 00073796343927 Omron Small D-ring Cuff HEM-CS24-B HEM-CS24-B 2019-04-03 00073796725310 Omron 5 Series Upper Arm Blood Pressure Monitor BP7250CAN BP7250CAN 2019-07-08 00073796735319 Omron 7 Series Upper Arm Blood Pressure Monitor BP7350CAN BP7350CAN 2019-07-08 00073796745318 Omron 10 Series Upper Arm Blood Pressure Monitor BP7450CAN BP7450CAN 2019-07-08 00073796893101 Blood Pressure Monitor BP9310T BP9310T 2022-07-01 00073796745530 Omron Blood Pressure Monitor BP7455CAN-CD6 BP7455CAN-CD6 2021-09-01 00073796100315 Omron 3 Series Upper Arm Blood Pressure Monitor BP7100CAN BP7100CAN 2019-07-08 00073796146054 AC Adapter for digital Blood Pressure Units HEM-ADPTW5 HEM-ADPTW5 2016-09-16 00073796149079 AC Adapter for HEM-907XL HEM-ADPT907 HEM-ADPT907 2016-09-16
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