Polysmith Version 11.0

GUDID 00817111020779

NEUROTRONICS, INC.

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Primary Device ID00817111020779
NIH Device Record Key74fe27ba-8b5f-41b8-aa39-e154523585a4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePolysmith Version 11.0
Version Model Number11.0
Company DUNS036405363
Company NameNEUROTRONICS, INC.
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817111020779 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-11
Device Publish Date2017-03-10

Devices Manufactured by NEUROTRONICS, INC.

00817111021172 - Polysmith Version 12.02020-04-09
00817111020748 - Polysmith Version 10.02019-12-11
00817111020755 - Polysmith Version 9.02019-12-11
00817111020779 - Polysmith Version 11.02019-12-11
00817111020779 - Polysmith Version 11.02019-12-11
00817111020786 - Live View Panel Version 1.32019-12-11 Live View Panel Version 1.3
00817111020816 - Live View Panel Version 1.42019-12-11 Live View Panel Version 1.4
00817111021141 - Nomad PMU800 Portable Recorder (USB)2019-05-09 Nomad PMU800 Portable Recorder (USB)
00817111021158 - Serenity PZ01 Piezo Sensor, 1.5mm DIN, 3.0m2019-05-09 Serenity PZ01 Piezo Sensor, 1.5mm DIN, 3.0m

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