Proteus Digital Health Feedback System

GUDID 00856602005222

PROTEUS DIGITAL HEALTH, INC.

Medication adherence telemetric monitoring system, post-ingestion
Primary Device ID00856602005222
NIH Device Record Key12d881cc-43f0-49e6-9d32-f7210b7c7e23
Commercial Distribution StatusIn Commercial Distribution
Brand NameProteus Digital Health Feedback System
Version Model NumberSPC-2330
Company DUNS149825791
Company NamePROTEUS DIGITAL HEALTH, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
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
GS100856602005222 [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 Date2018-08-02
Device Publish Date2018-07-02

On-Brand Devices [Proteus Digital Health Feedback System]

00856602005222SPC-2330
00856602005215SPC-2329
10856602005137SPC-2005

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