Revitive Electrode Body Pads 1570

GUDID 00858058005030

ACTEGY LIMITED

Transcutaneous electrical stimulation electrode
Primary Device ID00858058005030
NIH Device Record Key6eb06e15-5e56-4d9b-a50a-05dd7f5fa14c
Commercial Distribution StatusIn Commercial Distribution
Brand NameRevitive Electrode Body Pads
Version Model Number1570
Catalog Number1570
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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100858058005023 [Primary]
GS100858058005030 [Package]
Contains: 10858058005020
Package: Outer Carton [30 Units]
In Commercial Distribution
GS110858058005020 [Package]
Contains: 00858058005023
Package: Inner Carton [10 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 StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-23

On-Brand Devices [Revitive Electrode Body Pads]

008580580050301570
050602174921302044

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