TenderTrode™ A10001

GUDID 50813150020027

GRAPHIC CONTROLS ACQUISITION CORP

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

• Primary Device ID: 50813150020027
• NIH Device Record Key: fd804375-00f2-457b-bb22-61a078505ea9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TenderTrode™
• Version Model Number: A10001
• Catalog Number: A10001
• Company DUNS: 002111896
• Company Name: GRAPHIC CONTROLS ACQUISITION CORP
• Device Count: 3
• 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: 1.800.669.6905
• Email: customerservice@vermed.com
• Phone: 1.800.669.6905
• Email: customerservice@vermed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813150020022 [Unit of Use]
GS1	30813150020023 [Primary]
GS1	40813150020020 [Package]; Contains: 30813150020023; Package: box [25 Units]; In Commercial Distribution
GS1	50813150020027 [Package]; Contains: 40813150020020; Package: case [8 Units]; 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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-01-27

On-Brand Devices [TenderTrode™]

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