Polysmith

GUDID 00817111021332

Neurotronics, LLC

Sleep disorder interpretive software, professional-only
Primary Device ID00817111021332
NIH Device Record Key7b7b5da4-f44b-4e4e-bb65-cda93552d431
Commercial Distribution StatusIn Commercial Distribution
Brand NamePolysmith
Version Model Number12.3
Company DUNS036405363
Company NameNeurotronics, LLC
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
GS100817111021332 [Primary]

FDA Product Code

OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-10-01
Device Publish Date2025-09-23

Devices Manufactured by Neurotronics, LLC

00817111021332 - Polysmith2025-10-01
00817111021332 - Polysmith2025-10-01
00817111021264 - Live View Panel Pro Version 2.02024-05-17 Live View Panel Pro Version 2.0
00817111020540 - Echo Polysomnography Playback Unit2023-06-15
00817111021189 - NomadAir PMU810 Portable Recorder2023-04-14
00817111021196 - NomadAir PMU810 RIP Belt, Small2023-04-14
00817111021202 - NomadAir PMU810 RIP Belt, Medium2023-04-14
00817111021219 - NomadAir PMU810 RIP Belt, Large2023-04-14
00817111021257 - Polysmith Version 12.22023-04-14

Trademark Results [Polysmith]

Mark Image

Registration | Serial
Company
Trademark
Application Date
POLYSMITH
POLYSMITH
77276653 3430606 Live/Registered
Neurotronics, Inc.
2007-09-11

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