TenderTrode™ A10000-J(60)

GUDID 50009336008518

Infant and Pediatric ECG Electrodes

GRAPHIC CONTROLS ACQUISITION CORP

Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use Electrocardiographic electrode, single-use

• Primary Device ID: 50009336008518
• NIH Device Record Key: 9a3b13c1-f315-47ca-ad66-63f36a13e334
• Commercial Distribution Discontinuation: 2023-12-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: TenderTrode™
• Version Model Number: A10000-60
• Catalog Number: A10000-J(60)
• Company DUNS: 002111896
• Company Name: GRAPHIC CONTROLS ACQUISITION CORP
• Device Count: 60
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com
• Phone: 800-669-6905
• Email: info@vermed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00009336008513 [Unit of Use]
GS1	10009336008510 [Primary]
GS1	50009336008518 [Package]; Contains: 10009336008510; Package: [10 Units]; Discontinued: 2023-12-18; Not in Commercial Distribution

FDA Product Code

• DRX: Electrode, Electrocardiograph

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: 2023-12-19
• Device Publish Date: 2017-07-13

On-Brand Devices [TenderTrode™]

• 50813150020027: A10001
• 50009336008518: Infant and Pediatric ECG Electrodes