Revitive Electrode Body Pads

GUDID 05060217492130

ACTEGY LIMITED

Transcutaneous electrical stimulation electrode, single-use
Primary Device ID05060217492130
NIH Device Record Keyab133c65-7a8a-4198-9abc-d912c65713c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameRevitive Electrode Body Pads
Version Model Number2044
Company DUNS735575941
Company NameACTEGY LIMITED
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com
Phone8772603114
Emailus.info@actegy.com

Operating and Storage Conditions

Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 102 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS105060217490303 [Primary]
GS105060217490310 [Package]
Contains: 05060217490303
Package: Inner carton [10 Units]
In Commercial Distribution
GS105060217492130 [Package]
Contains: 05060217490303
Package: outer carton [300 Units]
In Commercial Distribution

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-12
Device Publish Date2021-05-04

On-Brand Devices [Revitive Electrode Body Pads]

008580580050301570
050602174921302044

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