DEVICE: Family Healthware™ (00860508000304)

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Device Identifier (DI) Information

Family Healthware™
Version 2.0 Released 20160615

SANITAS, INC.
00860508000304
GS1
1
Family Healthware™ is a self-administered, interactive Web-based software tool that assesses a person's familial risk for six diseases (coronary heart disease, stroke, diabetes, and colorectal, breast, and ovarian cancer). It provides users with a "prevention plan" containing personalized recommendations for lifestyle changes and screening. For each person, the tool collects data about the following: + Health behaviors (e.g., smoking and exercise); + Screening tests (e.g., blood cholesterol and mammography); + Health history among his or her first- and second-degree relatives. One set of algorithms in the software analyzes users' family history data and assesses their familial risk for each of the six diseases. A second set of algorithms uses the data on familial risk, health behaviors, and screening results to generate personalized prevention messages. The intended use is to utilize computerized family genomic data to increase disease risk perceptions and improve chronic disease management, thereby reducing the effects of these serious chronic disorders.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Self-care monitoring reporting software An application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional, and/or exercise information in the home, which may include medication administration information captured from enabled injection devices, and to provide care plan, journal, medication advice, and/or messaging functionalities.
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FDA Product Code

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Product Code Product Code Name
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
August 01, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Yes
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Yes
No CLOSE

Customer Contact

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(877) 504-6575
support@familyhealthware.com
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