Espion
GUDID 00855730007276
Profile System; with Xenon ColorDome and 100 Volt power supply 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). Configuration: D310-G-5-CDXR-N-N
DIAGNOSYS LLC
Electroretinograph| Primary Device ID | 00855730007276 |
| NIH Device Record Key | 01e680d3-dc30-4b8e-a402-5aa842b699a2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Espion |
| Version Model Number | D310 |
| Company DUNS | 131488467 |
| Company Name | DIAGNOSYS LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855730007276 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K863956
FDA Product Code
| GWE | Stimulator, Photic, Evoked Response |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-21 |
| Device Publish Date | 2021-04-13 |
On-Brand Devices [Espion]
| 00855730007153 | E3 System; with Xenon ColorDome and 27" Monitor is a clinical and research visual electrophysiol |
| 00855730007146 | Profile System; with 27" Monitor and Mini OLED on extendable arm is a clinical and research visu |
| 00855730007139 | Profile System; with Xenon ColorDome on an Operating Room Arm and ColorBurst (with stand) and Mi |
| 00855730007122 | Cart-only, no control unit, no power unit, with 27" Monitor is a clinical and research visual el |
| 00855730007115 | Profile System; with Xenon ColorDome on an Operating Room Arm is a clinical and research visual |
| 00855730007108 | Profile System; with 27" Monitor is a clinical and research visual electrophysiology system that |
| 00855730007092 | Profile System; with Xenon ColorDome on an Operating Room Arm is a clinical and research visual |
| 00855730007085 | Profile System; with 32" Monitor is a clinical and research visual electrophysiology system that |
| 00855730007078 | Cart-only, no control unit, with 23" Monitor is a clinical and research visual electrophysiology |
| 00855730007061 | Profile System; with Non-Xenon ColorDome is a clinical and research visual electrophysiology sys |
| 00855730007054 | Profile System; with 23" Monitor on an Operating Room Arm and ColorBurst and Mini OLED with tabl |
| 00855730007047 | Profile System; with 23" Monitor on an Operating Room Arm and Mini OLED with table stand & exten |
| 00855730007030 | Profile System; with 23" Monitor and ColorBurst and Mini OLED with table stand & extendable arm |
| 00855730007023 | Profile System; with 23" Monitor and Mini OLED with table stand & extendable arm is a clinical a |
| 00855730007016 | Profile System; with 32" Monitor and ColorBurst and Mini OLED with table stand & extendable arm |
| 00855730007009 | Profile System; with 32" Monitor and Mini OLED with table stand & extendable arm is a clinical a |
| 00850594007998 | Profile System; with 23" Monitor on an Operating Room Arm and ColorBurst and Mini OLED with exte |
| 00850594007981 | Profile System; with 23" Monitor on an Operating Room Arm and Mini OLED with extendable arm is a |
| 00850594007974 | Profile System; with 23" Monitor and ColorBurst and Mini OLED with extendable arm is a clinical |
| 00850594007967 | Profile System; with 23" Monitor and Mini OLED with extendable arm is a clinical and research vi |
| 00850594007950 | Profile System; with 32" Monitor and ColorBurst and Mini OLED with extendable arm is a clinical |
| 00850594007943 | Profile System; with 32" Monitor and Mini OLED with extendable arm is a clinical and research vi |
| 00850594007936 | Profile System; with Xenon ColorDome on an Operating Room Arm and ColorBurst and Mini OLED with |
| 00850594007929 | Profile System; with Non-Xenon ColorDome on an Operating Room Arm and ColorBurst and Mini OLED w |
| 00850594007912 | Profile System; with Xenon ColorDome and ColorBurst and Mini OLED with table stand & extendable |
| 00850594007905 | Profile System; with Non-Xenon ColorDome and ColorBurst and Mini OLED with table stand & extenda |
| 00850594007899 | Profile System; with ColorBurst and Mini OLED with table stand & extendable arm is a clinical an |
| 00850594007882 | Profile System; with Xenon ColorDome on an Operating Room Arm and Mini OLED with table stand & e |
| 00850594007875 | Profile System; with Non-Xenon ColorDome on an Operating Room Arm and Mini OLED with table stand |
| 00850594007868 | Profile System; with Xenon ColorDome and Mini OLED with table stand & extendable arm is a clinic |
| 00850594007851 | Profile System; with Non-Xenon ColorDome and Mini OLED with table stand & extendable arm is a cl |
| 00850594007844 | Profile System; with Xenon ColorDome on an Operating Room Arm and ColorBurst and Mini OLED with |
| 00850594007837 | Profile System; with Non-Xenon ColorDome on an Operating Room Arm and ColorBurst and Mini OLED w |
| 00850594007820 | Profile System; with Xenon ColorDome and ColorBurst and Mini OLED with extendable arm is a clini |
| 00850594007813 | Profile System; with Non-Xenon ColorDome and ColorBurst and Mini OLED with extendable arm is a c |
| 00850594007806 | Profile System; with ColorBurst and Mini OLED with extendable arm is a clinical and research vis |
| 00850594007790 | Profile System; with Xenon ColorDome on an Operating Room Arm and Mini OLED with extendable arm |
| 00850594007783 | Profile System; with Non-Xenon ColorDome on an Operating Room Arm and Mini OLED with extendable |
| 00850594007776 | Profile System; with Xenon ColorDome and Mini OLED with extendable arm is a clinical and researc |
| 00850594007769 | Profile System; with Non-Xenon ColorDome and Mini OLED with extendable arm with table stand is a |
| 00850594007752 | E3 System; with Mini OLED and no computer is a clinical and research visual electrophysiology sy |
| 00850594007745 | E3 System; with Mini OLED and Desktop Computer is a clinical and research visual electrophysiolo |
| 00850594007738 | E3 System; with Mini OLED and Tablet Computer is a clinical and research visual electrophysiolog |
| 00850594007721 | E3 system, 32-Bit Amplifier, All-in-One Touch Screen Computer with Espion S/W, Cart, and ColorBu |
| 00850594007714 | E3 system, 32-Bit Amplifier, All-in-One Touch Screen Computer with Espion S/W, Cart, and ColorBu |
| 00850594007707 | E3 System; with Non-Xenon ColorDome on an OR Stand and Mini OLED with table stand is a clinical |
| 00850594007691 | E3 System; with Non-Xenon ColorDome on an OR Stand and ColorBurst and Mini OLED with table stand |
| 00850594007684 | E3 System; with Non-Xenon ColorDome on an OR Stand and 23" Monitor and ColorBurst and Mini OLED |
| 00850594007677 | E3 System; with Non-Xenon ColorDome on an OR Stand and 23" Monitor and ColorBurst is a clinical |
| 00850594007660 | E3 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 88059226 not registered Live/Pending |
Diagnosys LLC 2018-07-31 |
 ESPION 87667747 5618883 Live/Registered |
JOYETECH EUROPE HOLDING GMBH 2017-11-01 |
 ESPION 86689382 5459403 Live/Registered |
Stratalis Ltd. 2015-07-10 |
 ESPION 78317572 3037542 Dead/Cancelled |
idée inc. 2003-10-23 |
 ESPION 78266627 not registered Dead/Abandoned |
Espion, LLC 2003-06-24 |
 ESPION 76158440 not registered Dead/Abandoned |
ESP Media Inc. 2000-11-02 |
 ESPION 76140330 not registered Dead/Abandoned |
ESP Media Inc. 2000-09-28 |
 ESPION 75195328 2191358 Dead/Cancelled |
SPY OPTIC INC. 1996-11-08 |
 ESPION 74249942 not registered Dead/Abandoned |
Asahi Kogaku Kogyo Kabushiki Kaisha 1992-02-25 |
 ESPION 73760498 not registered Dead/Abandoned |
BERKSHIRE ELECTRONICS LIMITED 1988-10-28 |
 ESPION 73738196 1525417 Dead/Cancelled |
ESPION, INC. 1988-07-05 |
 ESPION 73728187 1574459 Dead/Cancelled |
ADC TELECOMMUNICATIONS, INC. 1988-05-13 |
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