PERFORMA 554310

GUDID 10885914070700

PERFORMA VE - SMALL, 1.5 CC BOX OF 12

Performance Health Supply, LLC

Drug-delivery iontophoresis patch Drug-delivery iontophoresis patch Drug-delivery iontophoresis patch Drug-delivery iontophoresis patch Drug-delivery iontophoresis patch Drug-delivery iontophoresis patch Drug-delivery iontophoresis patch Drug-delivery iontophoresis patch Drug-delivery iontophoresis patch Drug-delivery iontophoresis patch Drug-delivery iontophoresis patch Drug-delivery iontophoresis patch Drug-delivery iontophoresis patch Drug-delivery iontophoresis patch Drug-delivery iontophoresis patch Drug-delivery iontophoresis patch Drug-delivery iontophoresis patch

• Primary Device ID: 10885914070700
• NIH Device Record Key: b0ccd25c-cdd7-49cf-a8d2-4f2215433112
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERFORMA
• Version Model Number: 554310
• Catalog Number: 554310
• Company DUNS: 966806150
• Company Name: Performance Health Supply, LLC
• Device Count: 12
• 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8003235547
• Email: customersupport@pattersonmedical.com
• Phone: 8003235547
• Email: customersupport@pattersonmedical.com
• Phone: 8003235547
• Email: customersupport@pattersonmedical.com
• Phone: 8003235547
• Email: customersupport@pattersonmedical.com
• Phone: 8003235547
• Email: customersupport@pattersonmedical.com
• Phone: 8003235547
• Email: customersupport@pattersonmedical.com
• Phone: 8003235547
• Email: customersupport@pattersonmedical.com
• Phone: 8003235547
• Email: customersupport@pattersonmedical.com
• Phone: 8003235547
• Email: customersupport@pattersonmedical.com
• Phone: 8003235547
• Email: customersupport@pattersonmedical.com
• Phone: 8003235547
• Email: customersupport@pattersonmedical.com
• Phone: 8003235547
• Email: customersupport@pattersonmedical.com
• Phone: 8003235547
• Email: customersupport@pattersonmedical.com
• Phone: 8003235547
• Email: customersupport@pattersonmedical.com
• Phone: 8003235547
• Email: customersupport@pattersonmedical.com
• Phone: 8003235547
• Email: customersupport@pattersonmedical.com
• Phone: 8003235547
• Email: customersupport@pattersonmedical.com

Device Dimensions

• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter
• Total Volume: 1.5 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885914070703 [Unit of Use]
GS1	10885914070700 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080580

FDA Product Code

• EGJ: Device, Iontophoresis, Other Uses

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: 2023-09-13
• Device Publish Date: 2017-02-24

On-Brand Devices [PERFORMA]

• 10885914070779: PERFORMA VE - BUTTERFLY 2.0CC
• 10885914070724: PERFORMA VE - LARGE, 4.0CC BOX OF 12
• 10885914070717: PERFORMA VE - MED, 2.5CC BOX OF 12
• 10885914070700: PERFORMA VE - SMALL, 1.5 CC BOX OF 12