FDA.reportPublic FDA data

BodyGuardian

Primary DI
00852132007149
Brand
BodyGuardian
Company
PREVENTICE TECHNOLOGIES, INC.
Model
BG2102
Device description
BodyGuardian Mini Plus Remote Monitoring System Kit
Published
2019-08-07
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
00852132007149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852132007149008521320071498521320071490852132007149

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiography telemetric monitoring systemAn assembly of devices designed to continuously measure and wirelessly transmit electrocardiographic (ECG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas).

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
00852132007392BodyGuardian KitL-632001KIT-BGMINI-EL2024-12-05
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
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