Omron Electrotherapy Pain Relief Long Life Pads PMLLPAD

GUDID 00073796226145

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 ID00073796226145
NIH Device Record Keyf572c38b-e7af-438f-9c55-a0128008e9cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmron Electrotherapy Pain Relief Long Life Pads
Version Model NumberPMLLPAD
Catalog NumberPMLLPAD
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

Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 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 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 41 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 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 41 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 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 41 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 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 41 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 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 41 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 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 41 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 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 41 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 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 41 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 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 41 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 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 41 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 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 41 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 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 41 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 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 41 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 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 41 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 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 41 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 104 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 40 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100073796226145 [Primary]
GS110073796226142 [Package]
Package: Inner Carton [12 Units]
In Commercial Distribution
GS120073796226149 [Package]
Contains: 10073796226142
Package: Case [4 Units]
In Commercial Distribution
GS150073796226140 [Package]
Package: boxes of 6 units [8 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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.