GD 040-183-4000

GUDID 00862186000379

The CAREpoint Workstation communication console is a standard radio/telephony communications console used for vice and data communications. Personal Computer (PC) based, it contains various means to interface to and control communications elements (i.e. 2 way radio, landline, wireless telephone) as which are commonly used for commercial and public safety (i.e. police, fire, EMS) communication purposes.

General Devices

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Primary Device ID00862186000379
NIH Device Record Key19d79e94-1462-4839-9554-dbf8ff33a2ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameGD
Version Model NumberCAREpoint Workstation
Catalog Number040-183-4000
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
GS100862186000379 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRGTransmitters And Receivers, Physiological Signal, Radiofrequency

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-23

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