Espion

GUDID 00855730007313

Attache is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).

DIAGNOSYS LLC

Electroretinograph Electroretinograph Electroretinograph Electroretinograph Electroretinograph Electroretinograph Electroretinograph Electroretinograph Electroretinograph Electroretinograph Electroretinograph Electroretinograph Electroretinograph Electroretinograph
Primary Device ID00855730007313
NIH Device Record Key05d0aa20-0557-40c1-864b-78c439f913af
Commercial Distribution StatusIn Commercial Distribution
Brand NameEspion
Version Model NumberD341
Company DUNS131488467
Company NameDIAGNOSYS LLC
Device Count1
DM Exempttrue
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-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100855730007313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWEStimulator, Photic, Evoked Response

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-04
Device Publish Date2021-04-26

On-Brand Devices [Espion]

00855730007153E3 System; with Xenon ColorDome and 27" Monitor is a clinical and research visual electrophysiol
00855730007146Profile System; with 27" Monitor and Mini OLED on extendable arm is a clinical and research visu
00855730007139Profile System; with Xenon ColorDome on an Operating Room Arm and ColorBurst (with stand) and Mi
00855730007122Cart-only, no control unit, no power unit, with 27" Monitor is a clinical and research visual el
00855730007115Profile System; with Xenon ColorDome on an Operating Room Arm is a clinical and research visual
00855730007108Profile System; with 27" Monitor is a clinical and research visual electrophysiology system that
00855730007092Profile System; with Xenon ColorDome on an Operating Room Arm is a clinical and research visual
00855730007085Profile System; with 32" Monitor is a clinical and research visual electrophysiology system that
00855730007078Cart-only, no control unit, with 23" Monitor is a clinical and research visual electrophysiology
00855730007061Profile System; with Non-Xenon ColorDome is a clinical and research visual electrophysiology sys
00855730007054Profile System; with 23" Monitor on an Operating Room Arm and ColorBurst and Mini OLED with tabl
00855730007047Profile System; with 23" Monitor on an Operating Room Arm and Mini OLED with table stand & exten
00855730007030Profile System; with 23" Monitor and ColorBurst and Mini OLED with table stand & extendable arm
00855730007023Profile System; with 23" Monitor and Mini OLED with table stand & extendable arm is a clinical a
00855730007016Profile System; with 32" Monitor and ColorBurst and Mini OLED with table stand & extendable arm
00855730007009Profile System; with 32" Monitor and Mini OLED with table stand & extendable arm is a clinical a
00850594007998Profile System; with 23" Monitor on an Operating Room Arm and ColorBurst and Mini OLED with exte
00850594007981Profile System; with 23" Monitor on an Operating Room Arm and Mini OLED with extendable arm is a
00850594007974Profile System; with 23" Monitor and ColorBurst and Mini OLED with extendable arm is a clinical
00850594007967Profile System; with 23" Monitor and Mini OLED with extendable arm is a clinical and research vi
00850594007950Profile System; with 32" Monitor and ColorBurst and Mini OLED with extendable arm is a clinical
00850594007943Profile System; with 32" Monitor and Mini OLED with extendable arm is a clinical and research vi
00850594007936Profile System; with Xenon ColorDome on an Operating Room Arm and ColorBurst and Mini OLED with
00850594007929Profile System; with Non-Xenon ColorDome on an Operating Room Arm and ColorBurst and Mini OLED w
00850594007912Profile System; with Xenon ColorDome and ColorBurst and Mini OLED with table stand & extendable
00850594007905Profile System; with Non-Xenon ColorDome and ColorBurst and Mini OLED with table stand & extenda
00850594007899Profile System; with ColorBurst and Mini OLED with table stand & extendable arm is a clinical an
00850594007882Profile System; with Xenon ColorDome on an Operating Room Arm and Mini OLED with table stand & e
00850594007875Profile System; with Non-Xenon ColorDome on an Operating Room Arm and Mini OLED with table stand
00850594007868Profile System; with Xenon ColorDome and Mini OLED with table stand & extendable arm is a clinic
00850594007851Profile System; with Non-Xenon ColorDome and Mini OLED with table stand & extendable arm is a cl
00850594007844Profile System; with Xenon ColorDome on an Operating Room Arm and ColorBurst and Mini OLED with
00850594007837Profile System; with Non-Xenon ColorDome on an Operating Room Arm and ColorBurst and Mini OLED w
00850594007820Profile System; with Xenon ColorDome and ColorBurst and Mini OLED with extendable arm is a clini
00850594007813Profile System; with Non-Xenon ColorDome and ColorBurst and Mini OLED with extendable arm is a c
00850594007806Profile System; with ColorBurst and Mini OLED with extendable arm is a clinical and research vis
00850594007790Profile System; with Xenon ColorDome on an Operating Room Arm and Mini OLED with extendable arm
00850594007783Profile System; with Non-Xenon ColorDome on an Operating Room Arm and Mini OLED with extendable
00850594007776Profile System; with Xenon ColorDome and Mini OLED with extendable arm is a clinical and researc
00850594007769Profile System; with Non-Xenon ColorDome and Mini OLED with extendable arm with table stand is a
00850594007752E3 System; with Mini OLED and no computer is a clinical and research visual electrophysiology sy
00850594007745E3 System; with Mini OLED and Desktop Computer is a clinical and research visual electrophysiolo
00850594007738E3 System; with Mini OLED and Tablet Computer is a clinical and research visual electrophysiolog
00850594007721E3 system, 32-Bit Amplifier, All-in-One Touch Screen Computer with Espion S/W, Cart, and ColorBu
00850594007714E3 system, 32-Bit Amplifier, All-in-One Touch Screen Computer with Espion S/W, Cart, and ColorBu
00850594007707E3 System; with Non-Xenon ColorDome on an OR Stand and Mini OLED with table stand is a clinical
00850594007691E3 System; with Non-Xenon ColorDome on an OR Stand and ColorBurst and Mini OLED with table stand
00850594007684E3 System; with Non-Xenon ColorDome on an OR Stand and 23" Monitor and ColorBurst and Mini OLED
00850594007677E3 System; with Non-Xenon ColorDome on an OR Stand and 23" Monitor and ColorBurst is a clinical
00850594007660E3 System; with Non-Xenon ColorDome on an OR Stand and 23" Monitor is a clinical and research vi

Trademark Results [Espion]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ESPION
ESPION
88059226 not registered Live/Pending
Diagnosys LLC
2018-07-31
ESPION
ESPION
87667747 5618883 Live/Registered
JOYETECH EUROPE HOLDING GMBH
2017-11-01
ESPION
ESPION
86689382 5459403 Live/Registered
Stratalis Ltd.
2015-07-10
ESPION
ESPION
78317572 3037542 Dead/Cancelled
idée inc.
2003-10-23
ESPION
ESPION
78266627 not registered Dead/Abandoned
Espion, LLC
2003-06-24
ESPION
ESPION
76158440 not registered Dead/Abandoned
ESP Media Inc.
2000-11-02
ESPION
ESPION
76140330 not registered Dead/Abandoned
ESP Media Inc.
2000-09-28
ESPION
ESPION
75195328 2191358 Dead/Cancelled
SPY OPTIC INC.
1996-11-08
ESPION
ESPION
74249942 not registered Dead/Abandoned
Asahi Kogaku Kogyo Kabushiki Kaisha
1992-02-25
ESPION
ESPION
73760498 not registered Dead/Abandoned
BERKSHIRE ELECTRONICS LIMITED
1988-10-28
ESPION
ESPION
73738196 1525417 Dead/Cancelled
ESPION, INC.
1988-07-05
ESPION
ESPION
73728187 1574459 Dead/Cancelled
ADC TELECOMMUNICATIONS, INC.
1988-05-13

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