GUDID 10856602005267

PROTEUS DIGITAL HEALTH, INC.

Medication adherence telemetric monitoring system transmitter
Primary Device ID10856602005267
NIH Device Record Keyb12797e5-6ce7-4c5a-8abc-1299ae43bb7b
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSPC-2232.B55
Company DUNS149825791
Company NamePROTEUS DIGITAL HEALTH, INC.
Device Count250
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
GS100856602005260 [Unit of Use]
GS110856602005267 [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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