FDA.reportPublic FDA data

Aware Breast Self-Exam Pad

Primary DI
00083059012071
Brand
Aware Breast Self-Exam Pad
Company
BIOMERICA, INC.
Model
1207
Device description
The Aware™ Pad is intended to be used as an aid for performing breast self-examination.
Published
2020-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991469000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991469000AWARE PADAac Consulting Group, Inc.1999-07-20IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00083059012071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00083059012071000830590120710830590120710083059012071

GMDN Terms#

Term, Definition table
TermDefinition
Breast self-examination padA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 949 645 2111info@biomerica.com

Regulatory Flags#

DUNS number
067647321
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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08305900070330HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT70332016-12-07
00083059070330HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT70332020-07-01
08305900010015EZ Detect Fecal Occult Blood Test10012016-12-08
08305900100013EZ Detect Colon Disease Test1000-12016-12-08
00083059010015EZ Detect Fecal Occult Blood Test10012020-07-01
00083059100013EZ Detect Colon Disease Test1000-12020-07-01
08305901007151EZ-SALMONELLA One-Step Salmonella species Rapid Test1007-152016-12-08
00083059100754EZ-SALMONELLA One-Step Salmonella species Rapid Test1007-152020-07-01
08305900012033Aware Breast Self-Exam Pad12032016-12-07
08305900070040GAP®-IgG (Gastritis and Peptic Ulcer Test)70042016-12-08
08305900070231ACTH [Adrenocorticotropic Hormone] ELISA70232016-12-07
08305900070248Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay]70242016-12-07
08305900070255EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay]70252016-12-07
08305900070309Myoglobin Enzyme Immunoassay Test Kit70302016-12-07
08305900070316TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KIT70312016-12-08
08305900070637Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay]70632016-12-08
08305900070699Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay]70692016-12-08
08305900070781E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay]70782016-12-08
08305901048253EZ-hCG Urine Pregnancy Test1048-252016-12-08

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