FDA.reportPublic FDA data

NA

Primary DI
10856602005014
Brand
NA
Company
PROTEUS DIGITAL HEALTH, INC.
Model
SPC-0800
Published
2016-07-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DXHTRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXHTransmitters And Receivers, Electrocardiograph, TelephoneCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133263000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133263000PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY)Proteus Digital Health, Inc.2014-02-07OZW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856602005014PackageGS16In Commercial Distribution
00856602005017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085660200501410856602005014
00856602005017008566020050178566020050170856602005017

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
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DXH2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DXH2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2026-06-03
05419980589309FibriCheckQompiumDXH2026-05-06
05419980589316FibriCheckQompiumDXH2026-05-06
05419980589323FibriCheckQompiumDXH2026-05-06
05419980589347FibriCheckQompiumDXH2026-05-06
00195278343512CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DXH2026-02-11
00198953107263MACGe Medical Systems Information Technologies, Inc.DXH2026-01-27
07290008960380SmartheartSHL TELEMEDICINE INTERNATIONAL LTD.DXH2025-12-09
04719872981756QT ECGQt Medical, Inc.DXH2025-05-12
B353UB22511UbiqVue HolterLifesignals, Inc.DXH2025-04-22
B353UA2251R1UbiqVue Lifesignals, Inc.DXH2025-04-22
00195278421456CAMGE Medical Systems Information Technologies, Inc.DXH2025-04-07
00812324000297GEMS Mobile ECGCardioComm Solutions, IncDXH2025-03-20
B210AC0290K1000Alivecor, Inc.DXH2025-03-18
00840682144322MACGE Medical Systems Information Technologies, Inc.DXH2025-03-13
00860006382308SENSINEL™ CPM REPLACEMENT ADHESIVE PADAnalog Devices, Inc.DXH2025-03-13
00860006382315SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2025-03-13
00860006382322SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DXH2025-03-13
00860006382339SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DXH2025-03-13
00860006382346SENSINEL™ CPM ALIGNMENT TOOLAnalog Devices, Inc.DXH2025-03-13
20860006382302SENSINEL™ CPM REPLACEMENT ADHESIVES (15 Pack)Analog Devices, Inc.DXH2025-03-13
08908013617128Frontier X PlusFOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITEDDXH2025-02-07
00850043907046Zio ECG Utilization Software (ZEUS) SystemIRHYTHM TECHNOLOGIES, INC.DXH2024-07-26
04719872981527QT ECGQt Medical, Inc.DXH2024-07-08
04719872981534QT ECGQt Medical, Inc.DXH2024-07-08
00856298006428EZLink-RSCOTTCARE CORPORATION, THEDXH2024-05-23
00856298006435EZLink-CSCOTTCARE CORPORATION, THEDXH2024-05-23