FDA.reportPublic FDA data

BodyGuardian Mini Short Slide Strip

Primary DI
00852132007231
Brand
BodyGuardian Mini Short Slide Strip
Company
PREVENTICE TECHNOLOGIES, INC.
Model
SP2006
Catalog number
SP2006
Device description
Mini Short Slide Strip - Acrylic
Published
2021-09-15
Public version status
Update
Distribution status
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
00852132007231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852132007231008521320072318521320072310852132007231

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
00851491007555AccuSensorLynn Medical Instrument Co.DRX2026-07-28
00851491007562AccuSensorLynn Medical Instrument Co.DRX2026-07-24
G828HARNESS0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
G828PACKAGE0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
20192253016663KendallCardinal Health 200, LLCDRX2024-02-28
20192253016670KendallCardinal Health 200, LLCDRX2024-02-28
20192253017424KendallCardinal Health 200, LLCDRX2024-02-28
20192253017080KendallCardinal Health 200, LLCDRX2023-03-16
08033003267424NAFIAB SPADRX2021-03-31
20192253016755KendallCardinal Health 200, LLCDRX2021-02-23
20192253017196KendallCardinal Health 200, LLCDRX2020-11-17
08906035281044Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281174Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
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08906035282959Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282966Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282980Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20