FDA.reportPublic FDA data

GD

Primary DI
00862186000362
Brand
GD
Company
General Devices
Model
Prep-Check Plus, 68 pin
Catalog number
EIM-107-68B
Device description
The Prep-Check Plus, 68 pin is a hand-held, battery powered device intended to measure the electrical impedance of bio-potential electrodes applied to patients. It has 50 Lead EEG with 68 Pin Female sub-miniature Dual Inline Connector (50 Lead Wired) .
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
GZODevice, Galvanic Skin Response Measurement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZODevice, Galvanic Skin Response MeasurementNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993202000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993202000EIM-107 PREP-CHECKGeneral Devices1999-12-17GZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862186000362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862186000362008621860003628621860003620862186000362

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic electrode testerAn instrument designed to measure the electrical impedance between the surface of external electrocardiography electrodes and the skin; it is also typically capable of measuring interference voltages that may be stored on electrodes (i.e., offset voltage) and/or detect faulty lead wires and cables. The device is mainly used to assess the ability of a set of surface (skin) electrodes to conduct bioelectric signals from the skin to the electrodes; it can also measure the impedance of the lead wires and cables from the electrodes to the measuring unit. It is intended to be used by a healthcare provider in a clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
101394815
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862186000379GDCAREpoint Workstation040-183-40002016-09-23
00862186000331GDPrep-Check Plus, 25 pinEIM-107-25B2020-04-02
00862186000300GDPrep-Check 10HzEIM-105-10Hz 2016-09-23
00862186000317GDPrep-Check 30HzEIM-105-30Hz2016-09-23
00862186000324GDPrep-Check Plus, 20 pinEIM 107-20A2016-09-23
00862186000348GDPrep-Check Plus, 37 pinEIM 107-37A2016-09-23
00862186000355GDPrep-Check Plus, 50 pinEIM-107-50B2016-09-23
00862186000386GDRosetta-Lt Data Translator 040-184-71002016-09-23
00086186000331GDPrep-Check Plus, 25 pinEIM-107-25B2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05999860882046QUEX EDQX WORLD LTDGZO2026-04-27
05999860882053QUEX SQX WORLD LTDGZO2026-04-27
05999860882060QUEX EDQX WORLD LTDGZO2026-04-27
05999860882077QUEX SQX WORLD LTDGZO2026-04-27
00853858006546Empatica Health Monitoring PlatformEMPATICA SRLGZO2026-02-16
00853858006751Empatica Health Monitoring PlatformEMPATICA SRLGZO2026-02-16
00853858006584EmpaticaEMPATICA SRLGZO2025-06-26
00850068747092Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
00850068747108Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
00850068747115Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
00850068747122Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
00850068747139Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
00850068747146Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
00850068747153Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
00850068747160Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
00850068747177Happy HealthHAPPY HEALTH, INC.GZO2025-04-02
08690020003024SudoCheckMedeia, Inc.GZO2025-02-05
00840067103555Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-11-15
00840067103562Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-11-15
00840067103623Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-11-15
00840067103630Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-11-15
00840067103999CadwellCADWELL INDUSTRIES, INC.GZO2024-08-23
00840067102992Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-08-23
00840067103517Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-06-21
00840067103524Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-06-21
B322G0011ANS1 SoftwareLD TECHNOLOGY, LLCGZO2024-03-05
00840067102879Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-03-04
00840067102886Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-03-04
00840067102893Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-03-04
00840067102909Cadwell GuardianCADWELL INDUSTRIES, INC.GZO2024-03-04