PerformancePlus™ 10006-5

GUDID 20813150020439

GRAPHIC CONTROLS ACQUISITION CORP

Electrocardiographic electrode, single-use

• Primary Device ID: 20813150020439
• NIH Device Record Key: c6ec4eb4-da57-4bee-8716-1ea11fe8097e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PerformancePlus™
• Version Model Number: 10006-5
• Catalog Number: 10006-5
• Company DUNS: 002111896
• Company Name: GRAPHIC CONTROLS ACQUISITION CORP
• Device Count: 5
• 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	00813150020435 [Primary]
GS1	00813150020510 [Unit of Use]
GS1	10813150020432 [Package]; Contains: 00813150020435; Package: [20 Units]; In Commercial Distribution
GS1	20813150020439 [Package]; Contains: 10813150020432; Package: [6 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: 2016-09-16

On-Brand Devices [PerformancePlus™]

• 20813150020682: A10072-7
• 10813150020685: A10072-5
• 10813150020555: A10012-60S
• 20813150020446: A10012-5S
• 20813150020439: 10006-5
• 10813150020241: A10015-10S
• 10813150020180: A10005-7NB
• 10813150020128: A10005-60
• 10813150020104: A10005-4NB
• 00813150020671: A10072-3
• 70813150021080: A10072-1-7P
• 80813150020622: A10012-4-60S
• 70813150020229: 5 PER POUCH, 120 POUCHES PER CASE = 600 ELECTRODES
• 60813150021083: A10072-1-60
• 60813150020222: A10005-1-60
• 60813150021311: A10101-3
• 60813150020628: A10012-3S-30
• 40813150020433: 5 per Pouch, 10 pouches per Box = 50 600 per Case
• 40813150020228: A10005-10P
• 40813150021089: A10072-1-30
• 50009336008532: Electrodes for Stress and Holter Testing
• 10009336008527: Electrodes for Stress and Holter Testing