GD EIM-107-50B

GUDID 00862186000355

The Prep-Check Plus, 50 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 50 Pin Female "D" Connector (All 50 Pins Wired) .

General Devices

Electrocardiographic electrode tester
Primary Device ID00862186000355
NIH Device Record Key5404165f-bc5d-4097-8c8a-c4868198e026
Commercial Distribution StatusIn Commercial Distribution
Brand NameGD
Version Model NumberPrep-Check Plus, 50 pin
Catalog NumberEIM-107-50B
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
GS100862186000355 [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]

00086186000331The Prep-Check Plus, 25 pin is a hand-held, battery powered device intended to measure the elect
00862186000386The Rosetta-Lt Data Translator receives and communicates information from monitor/defibrillators
00862186000379The CAREpoint Workstation communication console is a standard radio/telephony communications con
00862186000362The Prep-Check Plus, 68 pin is a hand-held, battery powered device intended to measure the elect
00862186000355The Prep-Check Plus, 50 pin is a hand-held, battery powered device intended to measure the elect
00862186000348The Prep-Check Plus, 37 pin, is a hand-held, battery powered device intended to measure the ele
00862186000324The Prep-Check Plus, 20 pin model is a hand-held, battery powered device intended to measure the
00862186000317The Prep-Check 30Hz is a hand-held, battery powered device intended to measure the electrical im
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.