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| 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
| 10855730007426 - DTL 2 | 2024-11-19 A non-sterile electrical conductor intended to be applied adjacent to the eye to transmit an electrical signal during an evaluat |
| 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 |
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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