DEVICE: NA (00856602005017)

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Device Identifier (DI) Information

NA
SPC-0800

PROTEUS DIGITAL HEALTH, INC.
00856602005017
GS1
1
No description.
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Device Characteristics

MR Unsafe
No
No
Yes
Yes
No
No
No
No

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
Medication adherence telemetric monitoring system, post-ingestion An assembly of electronic devices intended to help assess the medication adherence of a patient who is self-managing oral medication by monitoring medication ingestion. It consists of a transmitter(s) intended to be swallowed by the patient with their medication, a patient worn transceiver with an electrode, and dedicated software. The transmitter activates upon wetting in the stomach, and transmits an electrical signal to the patient-worn transceiver, which records an event to confirm medication has been taken. The transceiver wirelessly communicates with an off-the-shelf device with the software installed, and may also record additional relevant data (e.g., heart rate, body angle).
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FDA Product Code

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Product Code Product Code Name
DXH TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE
OZW Ingestible event marker
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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
July 07, 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
10856602005014 6 00856602005017 In Commercial Distribution
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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)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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