Aware Breast Self-Exam Pad

GUDID 00083059012071

The Aware™ Pad is intended to be used as an aid for performing breast self-examination.

BIOMERICA, INC.

Breast self-examination pad Breast self-examination pad Breast self-examination pad Breast self-examination pad Breast self-examination pad Breast self-examination pad Breast self-examination pad Breast self-examination pad Breast self-examination pad Breast self-examination pad Breast self-examination pad Breast self-examination pad Breast self-examination pad

• Primary Device ID: 00083059012071
• NIH Device Record Key: 8d79aa69-b7ee-46f2-93bd-c7e2fd0fa06d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aware Breast Self-Exam Pad
• Version Model Number: 1207
• Company DUNS: 067647321
• Company Name: BIOMERICA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com
• Phone: +1 949 645 2111
• Email: info@biomerica.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083059012071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991469

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-09
• Device Publish Date: 2020-07-01

On-Brand Devices [Aware Breast Self-Exam Pad]

• 00083059012071: The Aware™ Pad is intended to be used as an aid for performing breast self-examination.
• 00083059012033: The Aware™ Pad is intended to be used as an aid for performing breast self-examination.
• 08305900012033: The Aware™ Pad is intended to be used as an aid for performing breast self-examination.