GD

Primary DI
00862186000317
Brand
GD
Company
General Devices
Model
Prep-Check 30Hz
Catalog number
EIM-105-30Hz
Device description
The Prep-Check 30Hz is a hand-held, battery powered device intended to measure the electrical impedance of bio-potential electrodes a applied to patients. Impedance readings are measured at 30 Hz.
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
KRCTester, Electrode, Surface, Electrocardiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRCTester, Electrode, Surface, ElectrocardiographicCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K830876000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K830876000PREP-CHECKGeneral Devices1983-05-18KRC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862186000317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862186000317008621860003178621860003170862186000317

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
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
00862186000362GDPrep-Check Plus, 68 pinEIM-107-68B2016-09-23
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
D040159110Quick mount FacebowWHIP-MIX CORPORATIONKRC2025-09-04
00884838020849SO2 Optical ModulePhilips Medizin Systeme Böblingen GmbHKRC2018-12-18
20884838072248Spirometry SensorPhilips Medizin Systeme Böblingen GmbHKRC2017-01-20
00862186000300GDGeneral DevicesKRC2016-09-23