UltraStim X Blue

GUDID 00851913006234

AXELGAARD MANUFACTURING CO., LTD.

Transcutaneous electrical stimulation electrode
Primary Device ID00851913006234
NIH Device Record Key34546cc4-d20c-4a19-9649-c52290348607
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltraStim X Blue
Version Model NumberUSXPB5000
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone(760)451-8004
Emailcustomerservice@axelgaard.com
Phone(760)451-8004
Emailcustomerservice@axelgaard.com
Phone(760)451-8004
Emailcustomerservice@axelgaard.com
Phone(760)451-8004
Emailcustomerservice@axelgaard.com
Phone(760)451-8004
Emailcustomerservice@axelgaard.com
Phone(760)451-8004
Emailcustomerservice@axelgaard.com
Phone(760)451-8004
Emailcustomerservice@axelgaard.com
Phone(760)451-8004
Emailcustomerservice@axelgaard.com
Phone(760)451-8004
Emailcustomerservice@axelgaard.com
Phone(760)451-8004
Emailcustomerservice@axelgaard.com
Phone(760)451-8004
Emailcustomerservice@axelgaard.com
Phone(760)451-8004
Emailcustomerservice@axelgaard.com
Phone(760)451-8004
Emailcustomerservice@axelgaard.com
Phone(760)451-8004
Emailcustomerservice@axelgaard.com
Phone(760)451-8004
Emailcustomerservice@axelgaard.com
Phone(760)451-8004
Emailcustomerservice@axelgaard.com
Phone(760)451-8004
Emailcustomerservice@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
GS100851913006234 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-07
Device Publish Date2018-08-07

On-Brand Devices [UltraStim X Blue]

00851913006234USXPB5000
00851913006043USXPB5010
00851913006036USXPB5050
00851913006326USXB50100
00851913006319USXB5050

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