Aware Breast Self-Exam Pad

Basic Information

• Brand Name: Aware Breast Self-Exam Pad
• Primary DI: 08305900012033
• Version / Model: 1203
• Company Name: BIOMERICA, INC.
• Labeler DUNS: 067647321
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-07
• Public Version: 4
• Public Version Date: 2021-09-02
• Public Version Status: Update
• Public Device Record Key: 1ca6430e-d524-4f21-b85a-0c085b7c5701
• Distribution End Date: 2020-07-01

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44007	Breast self-examination pad	A device intended to be used to perform a tactile self-breast examination for abnormalities, typically unfamiliar changes/lumps in the soft tissue of the breast. It is typically pouch-shaped and made of thin, flexible, plastic (e.g., polyurethane) that contains a small quantity of fluid silicone and/or air, allowing it to conform to the user's breast and reduce skin friction between the hand and the surface of the breast. The device will allow the user to sense subtle tissue density variations. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08305900012033	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K991469	000