Siesta 9007-0061-01

GUDID 09342451002112

Siesta 802 Basic EEG System w/o Software

COMPUMEDICS USA, INC.

Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder Electroencephalographic ambulatory recorder
Primary Device ID09342451002112
NIH Device Record Key4f58a7b1-a9d1-461a-931c-513a2bdb6358
Commercial Distribution StatusIn Commercial Distribution
Brand NameSiesta
Version Model NumberSiesta 802 Basic EEG System
Catalog Number9007-0061-01
Company DUNS111312307
Company NameCOMPUMEDICS USA, 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 Batchfalse
Serial Numbertrue
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
GS109342451002112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLVStandard 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 Date2020-12-24
Device Publish Date2020-12-16

On-Brand Devices [Siesta]

09342451001788Siesta 802 Basic PSG System w/o Software
09342451002112Siesta 802 Basic EEG System w/o Software

Trademark Results [Siesta]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SIESTA
SIESTA
98494903 not registered Live/Pending
Strong Industries, Inc.
2024-04-11
SIESTA
SIESTA
97328677 not registered Live/Pending
Solaray LLC
2022-03-24
SIESTA
SIESTA
97290169 not registered Live/Pending
Proven Winners North America LLC
2022-03-01
SIESTA
SIESTA
90332763 not registered Live/Pending
Rios, Marc
2020-11-20
SIESTA
SIESTA
90276110 not registered Live/Pending
Z&S Brands L.L.C.
2020-10-24
SIESTA
SIESTA
88820714 not registered Live/Pending
Sun & Company, LLC
2020-03-04
SIESTA
SIESTA
88275912 not registered Live/Pending
Kim, Hyung gon
2019-01-25
SIESTA
SIESTA
87327338 5368232 Live/Registered
Siemens Aktiengesellschaft
2017-02-07
SIESTA
SIESTA
87278091 5250400 Live/Registered
Simune Atomistics S.L.
2016-12-22
SIESTA
SIESTA
87208410 not registered Dead/Abandoned
Aquarius, corp.
2016-10-19
SIESTA
SIESTA
86074769 not registered Dead/Abandoned
Goodman Manufacturing Company, L.P.
2013-09-25
SIESTA
SIESTA
86010341 not registered Dead/Abandoned
BASF SE
2013-07-15

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