TENSPRODUCTS/TENSTRODE 4040TC-TP, 4040TC-MFR, 4040TC-JETT

GUDID 30816924020137

1.5" X 1.5" SQUARE TAN CLOTH ELECTRODE 4/PK

TENSPRODUCTS, INC.

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode 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 ID30816924020137
NIH Device Record Key9b1f12f2-1fbd-427c-bbbd-f49868f46204
Commercial Distribution StatusIn Commercial Distribution
Brand NameTENSPRODUCTS/TENSTRODE
Version Model Number4040TC
Catalog Number4040TC-TP, 4040TC-MFR, 4040TC-JETT
Company DUNS121251883
Company NameTENSPRODUCTS, 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-Counterfalse

Customer Support Contacts

Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com
Phone1-866-449-1010
Emailsales@tensproducts.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816924020136 [Primary]
GS100816924020365 [Package]
Contains: 00816924020136
Package: Inner Bag [10 Units]
In Commercial Distribution
GS110816924020133 [Package]
Contains: 00816924020136
Package: Inner Box [50 Units]
In Commercial Distribution
GS130816924020137 [Package]
Contains: 00816924020136
Package: Case [400 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 Number2
Public Version Date2019-11-21
Device Publish Date2018-07-12

On-Brand Devices [TENSPRODUCTS/TENSTRODE]

208169240203212" X 2" SQUARE TAN CLOTH ELECTRODE POLY BAG 4/PK
308169240202293" ROUND TAN CLOTH ELECTRODE 4/PK
308169240202052" X 3.5" RECTANGLE TAN CLOTH ELECTRODE 4/PK
308169240201992" X 2" SQUARE TAN CLOTH ELECTRODE 4/PK
308169240201822" ROUND TAN CLOTH ELECTRODE 4/PK
308169240201751.25" ROUND TAN CLOTH ELECTRODE 4/PK
308169240201511.75" X 3.75" RECTANGLE BLUE GEL PREWIRED ELECTRODE 4/PK
008169240201431.75" X 1.75" SENSITIVE SKIN BLUE GEL PREWIRED ELECTRODE 4/PK
308169240201371.5" X 1.5" SQUARE TAN CLOTH ELECTRODE 4/PK
308169240201204" X 6" BUTTERFLY WHITE FOAM ELECTRODE 1/PK
308169240200832" X 2" SQUARE WHITE FOAM ELECTRODE 4/PK
308169240200762" ROUND WHITE FOAM ELECTRODE 4/PK
2081692402006213" X 1.5" BACK STRAP WHITE FOAM ELECTRODE 1/PK
208169240200481.5" x 2.5" OVAL WHITE FOAM ELECTRODE 4/PK
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