Quik-Prep

GUDID 21081234502474

Electrodes

MORTARA INSTRUMENT, INC.

Electrocardiographic electrode, single-use

• Primary Device ID: 21081234502474
• NIH Device Record Key: 210c447f-3a13-46f9-bf90-0f88fec8c59f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quik-Prep
• Version Model Number: 031581-00
• Company DUNS: 062046149
• Company Name: MORTARA INSTRUMENT, INC.
• Device Count: 5
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-667-8272
• Email: techsupport@mortara.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812345024746 [Unit of Use]
GS1	10812345024743 [Primary]
GS1	21081234502474 [Package]; Contains: 10812345024743; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K821757

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: 4
• Public Version Date: 2020-06-29
• Device Publish Date: 2016-09-24

On-Brand Devices [Quik-Prep]

• 00812345029901: Electrode application system
• 00812345022780: Electrode application system
• 21081234502474: Electrodes
• 21081234502471: Electrodes