| Primary Device ID | 08305900012033 |
| NIH Device Record Key | 1ca6430e-d524-4f21-b85a-0c085b7c5701 |
| Commercial Distribution Discontinuation | 2020-07-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Aware Breast Self-Exam Pad |
| Version Model Number | 1203 |
| 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 |
| Phone | +1 949 645 2111 |
| info@biomerica.com | |
| Phone | +1 949 645 2111 |
| info@biomerica.com | |
| Phone | +1 949 645 2111 |
| info@biomerica.com | |
| Phone | +1 949 645 2111 |
| info@biomerica.com | |
| Phone | +1 949 645 2111 |
| info@biomerica.com | |
| Phone | +1 949 645 2111 |
| info@biomerica.com | |
| Phone | +1 949 645 2111 |
| info@biomerica.com | |
| Phone | +1 949 645 2111 |
| info@biomerica.com | |
| Phone | +1 949 645 2111 |
| info@biomerica.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08305900012033 [Primary] |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-09-02 |
| Device Publish Date | 2016-12-07 |
| 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. |