Omron Electrotherapy Pain Relief Long Life Pads PMLLPAD-L

GUDID 00073796261429

Electrotherapy Pain Relief Long Life Pads

Omron Healthcare, Inc.

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use
Primary Device ID00073796261429
NIH Device Record Keyf10b8542-294f-408d-a23d-638a9532a529
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmron Electrotherapy Pain Relief Long Life Pads
Version Model NumberPMLLPAD-L
Catalog NumberPMLLPAD-L
Company DUNS054318779
Company NameOmron Healthcare, 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com
Phone1-800-634-4350
Emailohiquality@omron.com

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100073796261429 [Primary]
GS110073796261426 [Package]
Package: Inner Carton [6 Units]
In Commercial Distribution
GS120073796261423 [Package]
Contains: 10073796261426
Package: Case [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

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 Date2017-05-17

On-Brand Devices [Omron Electrotherapy Pain Relief Long Life Pads]

00073796614324Electrotherapy Pain Relief Long Life Pads
00073796614317Electrotherapy Pain Relief Long Life Pads
00073796261429Electrotherapy Pain Relief Long Life Pads
00073796226145Electrotherapy Pain Relief Long Life Pads
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