Standalone
GUDID 00850594007004
Standalone 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 Electroretinograph Electroretinograph Electroretinograph| Primary Device ID | 00850594007004 |
| NIH Device Record Key | 65283248-4932-46b6-a0f5-00354a481837 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Standalone |
| Version Model Number | D175 |
| 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 |
| 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 | 00850594007004 [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 | 2023-06-09 |
| Device Publish Date | 2023-06-01 |
Devices Manufactured by DIAGNOSYS LLC
| 00850594007004 - Standalone | 2023-06-09Standalone 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). |
| 00850594007004 - Standalone | 2023-06-09 Standalone is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, |
| 00855730007290 - Espion | 2021-05-04 Profile is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and |
| 00855730007306 - Espion | 2021-05-04 E3 is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then |
| 00855730007313 - Espion | 2021-05-04 Attache is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and |
| 00855730007320 - Gold Lens | 2021-05-04 Gold Lens (Adult): A non-sterile corneal electrode intended to be applied to the eye to detect the electrical response of the re |
| 00855730007337 - Gold Lens | 2021-05-04 Gold Lens (Pediatric): A non-sterile corneal electrode intended to be applied to the eye to detect the electrical response of th |
| 00855730007276 - Espion | 2021-04-21 Profile System; with Xenon ColorDome and 100 Volt power supply is a clinical and research visual electrophysiology system that f |
| 00855730007283 - Espion | 2021-04-21 Profile System; with 27" Monitor and 100 Volt power supply is a clinical and research visual electrophysiology system that funct |
Trademark Results [Standalone]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STANDALONE 85710291 4491936 Live/Registered |
D.R. Thomas Enterprises, LLC 2012-08-22 |
 STANDALONE 85012704 not registered Dead/Abandoned |
Applied Lifescience Research Industries, Inc. 2010-04-13 |
 STANDALONE 78932328 not registered Dead/Abandoned |
Jensen, Laina M. 2006-07-18 |
 STANDALONE 77666553 3675952 Live/Registered |
PIETZ, JASON 2009-02-09 |
 STANDALONE 74411651 1846771 Live/Registered |
PACIFIC PACKAGING PRODUCTS, INC. 1993-07-09 |
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