FDA.reportPublic FDA data

Proteus Digital Health Feedback System

Primary DI
10856602005137
Brand
Proteus Digital Health Feedback System
Company
PROTEUS DIGITAL HEALTH, INC.
Model
SPC-2005
Published
2018-07-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
OZWIngestible event marker

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZWIngestible Event MarkerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150494000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150494000Proteus Digital Health Feedback DeviceProteus Digital Health, Inc.2015-06-27OZW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856602005137PackageGS12In Commercial Distribution
20856602005134PackageGS16In Commercial Distribution
00856602005130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085660200513710856602005137
2085660200513420856602005134
00856602005130008566020051308566020051300856602005130

GMDN Terms#

Term, Definition table
TermDefinition
Medication adherence telemetric monitoring system, post-ingestionAn 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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
149825791
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10856602005021NASPC-0572.B022016-07-07
10856602005045NASPC-0572.B522016-07-07
10856602005052NASPC-0572.B552016-07-07
10856602005069NASPC-0572.B592016-07-07
10856602005076NASPC-0572.B502016-07-07
10856602005083NASPC-1330.B522016-09-22
10856602005090NASPC-1330.B022016-09-22
10856602005106NASPC-1330.B552016-09-22
10856602005113NASPC-1330.B502016-09-22
10856602005120NASPC-1330.B592016-09-22
10856602005168NASPC-2032.B022018-05-18
10856602005175NASPC-2032.B502018-05-18
10856602005182NASPC-2032.B522018-05-18
10856602005199NASPC-2032.B552018-05-18
10856602005205NASPC-2032.B592018-05-18
10856602005236NASPC-2232.B022019-07-12
10856602005243NASPC-2232.B502019-07-12
10856602005250NASPC-2232.B522019-07-12
10856602005267NASPC-2232.B552019-07-12
10856602005274NASPC-2232.B592019-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857335005114Otsuka Digital Feedback DeviceOtsuka America Pharmaceutical IncOZW2026-05-11
10856602005236NAPROTEUS DIGITAL HEALTH, INC.OZW2019-07-12
10856602005243NAPROTEUS DIGITAL HEALTH, INC.OZW2019-07-12
10856602005250NAPROTEUS DIGITAL HEALTH, INC.OZW2019-07-12
10856602005267NAPROTEUS DIGITAL HEALTH, INC.OZW2019-07-12
10856602005274NAPROTEUS DIGITAL HEALTH, INC.OZW2019-07-12
20856602005172NAPROTEUS DIGITAL HEALTH, INC.OZW2019-07-12
10856602005144Proteus Digital Health Feedback SystemPROTEUS DIGITAL HEALTH, INC.OZW2018-07-02
00856602005130Proteus Digital Health Feedback SystemPROTEUS DIGITAL HEALTH, INC.OZW2018-07-02
00856602005215Proteus Digital Health Feedback SystemPROTEUS DIGITAL HEALTH, INC.OZW2018-07-02
00856602005222Proteus Digital Health Feedback SystemPROTEUS DIGITAL HEALTH, INC.OZW2018-07-02
10856602005168NAPROTEUS DIGITAL HEALTH, INC.OZW2018-05-18
10856602005175NAPROTEUS DIGITAL HEALTH, INC.OZW2018-05-18
10856602005182NAPROTEUS DIGITAL HEALTH, INC.OZW2018-05-18
10856602005199NAPROTEUS DIGITAL HEALTH, INC.OZW2018-05-18
10856602005205NAPROTEUS DIGITAL HEALTH, INC.OZW2018-05-18
00856602005154NAPROTEUS DIGITAL HEALTH, INC.OZW2017-05-08
10856602005083NAPROTEUS DIGITAL HEALTH, INC.OZW2016-09-22
10856602005090NAPROTEUS DIGITAL HEALTH, INC.OZW2016-09-22
10856602005106NAPROTEUS DIGITAL HEALTH, INC.OZW2016-09-22
10856602005113NAPROTEUS DIGITAL HEALTH, INC.OZW2016-09-22
10856602005120NAPROTEUS DIGITAL HEALTH, INC.OZW2016-09-22
00856602005017NAPROTEUS DIGITAL HEALTH, INC.OZW2016-07-07
10856602005021NAPROTEUS DIGITAL HEALTH, INC.OZW2016-07-07
10856602005045NAPROTEUS DIGITAL HEALTH, INC.OZW2016-07-07
10856602005052NAPROTEUS DIGITAL HEALTH, INC.OZW2016-07-07
10856602005069NAPROTEUS DIGITAL HEALTH, INC.OZW2016-07-07
10856602005076NAPROTEUS DIGITAL HEALTH, INC.OZW2016-07-07