DEVICE: Sanitas™ Clinical Care Platform (00860508000311)

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Device Identifier (DI) Information

Sanitas™ Clinical Care Platform
Version 3.0 Released 20160615

SANITAS, INC.
00860508000311
GS1
1
The Sanitas™ Clinical Care Platform is a software system that collects patient physiological data (such as blood pressure and blood sugar levels) for transmission to a secure central storage server, which can be accessed by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. These data are also available to the patient for viewing purposes and as an aid in maintaining wellness regiments. The Sanitas™ Clinical Care Platform is an accessory software application that is used by patients in non-clinical settings (e.g. home), to collect, record and transmit their physiological information to a remote secure server. Stored data is accessible by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. The Sanitas Clinical Care Platform is also intended to be used in combination with a variety of external vital sign devices. The Sanitas Clinical Care Platform does not measure, interpret or make any decisions on the data that it conveys. It is not intended as a replacement for the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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Yes
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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

No
No
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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No
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None
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Production Identifier(s) in UDI

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Yes
No
No
Yes
No CLOSE

Customer Contact

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(877) 504-6575
support@sanitasinc.com
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