GUDID 10856602005243

PROTEUS DIGITAL HEALTH, INC.

Medication adherence telemetric monitoring system transmitter
Primary Device ID10856602005243
NIH Device Record Key81bdb9bf-2024-4145-b716-5e46232065b4
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSPC-2232.B50
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
GS100856602005246 [Unit of Use]
GS110856602005243 [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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.