TENSPRODUCTS/TENSTRODE BWT11-TP, BWT11-MFR, BWT11-JETT

GUDID 00816924020143

1.75" X 1.75" SENSITIVE SKIN BLUE GEL PREWIRED 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 ID00816924020143
NIH Device Record Key7d0fb760-2b2a-4b8b-9952-17b6c613ebcd
Commercial Distribution StatusIn Commercial Distribution
Brand NameTENSPRODUCTS/TENSTRODE
Version Model NumberBWT11
Catalog NumberBWT11-TP, BWT11-MFR, BWT11-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 HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
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
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100816924020143 [Primary]
GS110816924020140 [Package]
Package: Inner Box [40 Units]
In Commercial Distribution
GS130816924020144 [Package]
Package: Case [320 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]

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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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