PALS CLINICAL

GUDID 00851913006258

2" X 4" rectangle

AXELGAARD MANUFACTURING CO., LTD.

Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable

• Primary Device ID: 00851913006258
• NIH Device Record Key: 9fdc6eb9-e998-4d23-ad99-07b495b3904c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PALS CLINICAL
• Version Model Number: 210240
• Company DUNS: 150959401
• Company Name: AXELGAARD MANUFACTURING CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com
• Phone: 760-451-8000
• Email: support@axelgaard.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851913006258 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132422

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-14
• Device Publish Date: 2023-06-06

On-Brand Devices [PALS CLINICAL]

• 00851913006258: 2" X 4" rectangle
• 00851913006241: 2" x 2" square