FDA.reportPublic FDA data

NA

Primary DI
10856602005267
Brand
NA
Company
PROTEUS DIGITAL HEALTH, INC.
Model
SPC-2232.B55
Published
2019-07-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DXHTRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE
OZWIngestible event marker

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXHTransmitters And Receivers, Electrocardiograph, TelephoneCardiovascular2
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
10856602005267PrimaryGS10
00856602005260Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085660200526710856602005267
00856602005260008566020052608566020052600856602005260

GMDN Terms#

Term, Definition table
TermDefinition
Medication adherence telemetric monitoring system transmitterA non-sterile component of a medication adherence telemetric monitoring system intended to be ingested simultaneously with medication to transmit an electrical signal across tissues to a patient worn transceiver indicating that the medication has been taken. It is typically a transmitter housed in a placebo tablet which activates upon wetting (i.e., in the stomach). It does not include any active pharmaceuticals and is not intended for measuring physiological parameters.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
149825791
Device count
250
DM exempt
true
Lot or batch
true
Expiration date on label
true

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
10856602005274NASPC-2232.B592019-07-12
20856602005172NASPC-25202019-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857335005114Otsuka Digital Feedback DeviceOtsuka America Pharmaceutical IncOZW2026-05-11
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
B210AC0110KardiaBand SystemAlivecor, Inc.DXH2024-03-22
03700546708275Withings®WITHINGSDXH2023-09-07
03700546708435Withings®WITHINGSDXH2023-08-30