ValuTrode Cloth

GUDID 00856817005000

AXELGAARD MANUFACTURING CO., LTD.

Transcutaneous electrical stimulation electrode
Primary Device ID00856817005000
NIH Device Record Key1aaa7fac-6006-4420-acb4-7f569aa7db27
Commercial Distribution StatusIn Commercial Distribution
Brand NameValuTrode Cloth
Version Model NumberCF3200
Company DUNS150959401
Company NameAXELGAARD MANUFACTURING CO., LTD.
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 Usetrue
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

Phone(760)451-8000
Emailsupport@axelgaard.com
Phone(760)451-8000
Emailsupport@axelgaard.com
Phone(760)451-8000
Emailsupport@axelgaard.com
Phone(760)451-8000
Emailsupport@axelgaard.com
Phone(760)451-8000
Emailsupport@axelgaard.com
Phone(760)451-8000
Emailsupport@axelgaard.com
Phone(760)451-8000
Emailsupport@axelgaard.com
Phone(760)451-8000
Emailsupport@axelgaard.com
Phone(760)451-8000
Emailsupport@axelgaard.com
Phone(760)451-8000
Emailsupport@axelgaard.com
Phone(760)451-8000
Emailsupport@axelgaard.com
Phone(760)451-8000
Emailsupport@axelgaard.com
Phone(760)451-8000
Emailsupport@axelgaard.com
Phone(760)451-8000
Emailsupport@axelgaard.com
Phone(760)451-8000
Emailsupport@axelgaard.com
Phone(760)451-8000
Emailsupport@axelgaard.com
Phone(760)451-8000
Emailsupport@axelgaard.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100856817005000 [Primary]

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 Date2016-03-31

On-Brand Devices [ValuTrode Cloth]

00856817005086CF5010
00856817005079CF4065
00856817005062CF7515
00856817005055CF5090
00856817005048CF4090
00856817005031CF5050
00856817005024CF7000
00856817005017CF5000
00856817005000CF3200
00851913006128CF3050
00851913006050CF1020

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