FDA.reportPublic FDA data

BodyGuardian

Primary DI
00852132007033
Brand
BodyGuardian
Company
PREVENTICE TECHNOLOGIES, INC.
Model
SP1003
Device description
Strip - Acrylic 1003
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DRXElectrode, Electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852132007033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852132007033008521320070338521320070330852132007033

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic electrode, single-useA non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
859807815
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
00852132007149BodyGuardianBG21022019-08-07
00852132007002BodyGuardianBG10012016-09-21
00852132007026BodyGuardianSP10072016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G828HARNESS0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
G828PACKAGE0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
20192253017080KendallCardinal Health 200, LLCDRX2023-03-16
08033003267424NAFIAB SPADRX2021-03-31
08906035281044Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281174Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281501Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281525Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281532Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281549Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
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08906035281600Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282829Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282881Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282898Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
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08906035282911Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282942Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282959Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282966Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282980Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283017Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283024Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283048Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283055Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283062Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283079Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283086Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20