GD EIM-107-25B

GUDID 00086186000331

The Prep-Check Plus, 25 pin is a hand-held, battery powered device intended to measure the electrical impedance of bio-potential electrodes applied to patients. It has 25 Lead EEG with 25 Pin Female "D" Connector (All 25 Pins Wired) .

General Devices

Electrocardiographic electrode tester
Primary Device ID00086186000331
NIH Device Record Key84907577-a024-4129-b1c2-89f436414fe3
Commercial Distribution StatusIn Commercial Distribution
Brand NameGD
Version Model NumberPrep-Check Plus, 25 pin
Catalog NumberEIM-107-25B
Company DUNS101394815
Company NameGeneral Devices
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100086186000331 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZODevice, Galvanic Skin Response Measurement

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [GD]

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00862186000300The Prep-Check 10Hz is a hand-held, battery powered device intended to measure the electrical im
00862186000331The Prep-Check Plus, 25 pin is a hand-held, battery powered device intended to measure the elect

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