FDA.reportPublic FDA data

BodyGuardian Kit

Primary DI
00852132007392
Brand
BodyGuardian Kit
Company
PREVENTICE TECHNOLOGIES, INC.
Model
L-63
Catalog number
2001KIT-BGMINI-EL
Device description
BodyGuardian Mini Holter EL Kit - Arden Hills
Published
2024-12-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DSIDetector And Alarm, Arrhythmia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSIDetector And Alarm, ArrhythmiaCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850028319024PreviousGS10
00852132007392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850028319024008500283190248500283190240850028319024
00852132007392008521320073928521320073920852132007392

GMDN Terms#

Term, Definition table
TermDefinition
Medical networking interface unitAn electronic unit or device assembly intended to be used to interface one or more noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor/monitoring system) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be an ethernet router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
859807815
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852132007248BodyGuardian OneBG30032021-06-16
00852132007286PatientCare PlatformSW10012021-06-16
00852132007293BodyGuardian ConnectSW10022021-06-16
00852132007309ECG Plug-InSW10032021-06-16
00852132007316PatientCare LinkSW10042021-06-16
00852132007453BodyGuardian KitL-672001KIT-BGMINI-EL-CEM-LITE2025-06-11
00852132007491BodyGuardian KitL-662001KIT-BGMINI-SL-CEM-LITE2025-06-11
00852132007408BodyGuardian KitL-442001KIT-BGMINI-SL2024-12-05
00852132007415BodyGuardian KitL-452001KIT-BGMINIPLUS-SL2024-12-05
00852132007422BodyGuardian KitL-642001KIT-BGMINIPLUS-EL2024-12-05
00852132007439BodyGuardian KitL-532001KIT-BGMINIPLUS-EL-LITE2024-12-05
00852132007446BodyGuardian KitL-462001KIT-BGONE-4GVZW2024-12-05
00852132007194BodyGuardian Mini Short Slide StripSP2005SP20052021-06-30
00852132007217BodyGuardian Mini Monitoring System KitBG20042021-06-16
00852132007224BodyGuardian Mini Plus Monitoring System KitBG21042021-06-16
00852132007125BodyGuardianBG20022019-08-07
00852132007149BodyGuardianBG21022019-08-07
00852132007002BodyGuardianBG10012016-09-21
00852132007026BodyGuardianSP10072016-09-21
00852132007033BodyGuardianSP10032016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838119130Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-26
20884838119233Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-26
20884838119240Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-26
20884838119769Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-19
20884838119776Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHDSI2026-05-19
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2026-04-17
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyDSI2026-04-15
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2026-03-09
00195278343383CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DSI2026-02-11
00195278343512CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DSI2026-02-11
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2025-11-17
00884838127463Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2025-11-17
00884838128729C6 Monitor A13, VerizonBRAEMAR MANUFACTURING, LLCDSI2025-10-06
00884838128736C6 Monitor A13, T MobileBRAEMAR MANUFACTURING, LLCDSI2025-10-06
06944413838406Patient Monitor Edan Instruments, Inc.DSI2025-09-05
06944413838413Patient MonitorEdan Instruments, Inc.DSI2025-09-05
06944413838420Patient MonitorEdan Instruments, Inc.DSI2025-09-05
06944413838437Patient MonitorEdan Instruments, Inc.DSI2025-09-05
06944413838444Patient MonitorEdan Instruments, Inc.DSI2025-09-05
06944413838451Patient MonitorEdan Instruments, Inc.DSI2025-09-05
00884838127432Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2025-05-06
00884838127449Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2025-05-06
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DSI2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DSI2024-12-19
00884838123717Care AssistPhilips Medical Systems HsgDSI2024-11-27
00884838123724Care AssistPhilips Medical Systems HsgDSI2024-11-27
00850043907046Zio ECG Utilization Software (ZEUS) SystemIRHYTHM TECHNOLOGIES, INC.DSI2024-07-26
06944413815889Patient MonitorEdan Instruments, Inc.DSI2024-06-17
06944413815896Patient MonitorEdan Instruments, Inc.DSI2024-06-17