GUDID 20856602005172

PROTEUS DIGITAL HEALTH, INC.

Medication adherence telemetric monitoring system transmitter
Primary Device ID20856602005172
NIH Device Record Keyfd809bc0-2819-4f3d-9015-3a2cac443fd4
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSPC-2520
Company DUNS149825791
Company NamePROTEUS DIGITAL HEALTH, INC.
Device Count30
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100856602005178 [Unit of Use]
GS120856602005172 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OZWIngestible event marker

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-22
Device Publish Date2019-07-12

Devices Manufactured by PROTEUS DIGITAL HEALTH, INC.

10856602005021 - NA2022-11-28
10856602005045 - NA2022-11-28
10856602005052 - NA2022-11-28
10856602005069 - NA2022-11-28
10856602005076 - NA2022-11-28
10856602005083 - NA2022-11-28
10856602005090 - NA2022-11-28
10856602005106 - NA2022-11-28

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