ValuTrode Foam

GUDID 00856817005123

AXELGAARD MANUFACTURING CO., LTD.

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 ID: 00856817005123
• NIH Device Record Key: 93dc71f3-3b9f-48fa-96cc-67a65556848c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ValuTrode Foam
• Version Model Number: CFF202
• 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: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856817005123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130987

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-31

On-Brand Devices [ValuTrode Foam]

• 00856817005178: CFF204
• 00856817005161: CFF152
• 00856817005154: CFF305
• 00856817005147: CFF203
• 00856817005130: CFF153
• 00856817005123: CFF202
• 00856817005116: CFF275
• 00856817005109: CFF200
• 00856817005093: CFF125