PALS CLINICAL

GUDID 00851913006258

2" X 4" rectangle

AXELGAARD MANUFACTURING CO., LTD.

Transcutaneous electrical stimulation electrode, reusable
Primary Device ID00851913006258
NIH Device Record Key9fdc6eb9-e998-4d23-ad99-07b495b3904c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePALS CLINICAL
Version Model Number210240
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 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-Countertrue

Customer Support Contacts

Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
Emailsupport@axelgaard.com
Phone760-451-8000
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
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100851913006258 [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 Date2023-06-14
Device Publish Date2023-06-06

On-Brand Devices [PALS CLINICAL]

008519130062582" X 4" rectangle
008519130062412" x 2" square

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