Volista
GUDID 03700712435578
VCSII40SF TK XHS016 SAX1012
MAQUET SAS
Operating room light| Primary Device ID | 03700712435578 |
| NIH Device Record Key | 52a27478-f615-4f5b-970a-2c07a6a26827 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Volista |
| Version Model Number | ARDVCS639019A |
| Company DUNS | 264700139 |
| Company Name | MAQUET SAS |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03700712435578 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K130513
FDA Product Code
| FSY | Light, surgical, ceiling mounted |
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 | 2025-06-13 |
| Device Publish Date | 2025-06-05 |
On-Brand Devices [Volista]
| 03700712419332 | VST60DF SAT TK AIM 13 |
| 03700712419325 | VST60DF SAT TK AIM 12 |
| 03700712419318 | VST60SF SAT TK AIM 13 |
| 03700712419301 | VST60SF SAT TK AIM 12 |
| 03700712419295 | VST40DF SAT TK AIM 13 |
| 03700712419288 | VST40DF SAT TK AIM 12 |
| 03700712419271 | VST40SF SAT TK AIM 13 |
| 03700712419264 | VST40SF SAT TK AIM 12 |
| 03700712419233 | VST64DF VP TK AIM 0810 |
| 03700712419226 | VST64SF VP TK AIM 1011 |
| 03700712419219 | VST66DF VP TK AIM 0810 |
| 03700712419202 | VST66SF VP TK AIM 1011 |
| 03700712419196 | VST60DF VP TK AIM 08 |
| 03700712419189 | VST60SF VP TK AIM 11 |
| 03700712419172 | VST44DF VP TK AIM 0810 |
| 03700712419165 | VST44SF VP TK AIM 1011 |
| 03700712419158 | VST40DF VP TK AIM 08 |
| 03700712419141 | VST40SF VP TK AIM 11 |
| 03700712419134 | VST64DF TK AIM 0810 |
| 03700712419127 | VST64SF TK AIM 1011 |
| 03700712419110 | VST66DF TK AIM 0810 |
| 03700712419103 | VST66SF TK AIM 1011 |
| 03700712419097 | VST60DF TK AIM 08 |
| 03700712419080 | VST60SF TK AIM 11 |
| 03700712419073 | VST44DF TK AIM 0810 |
| 03700712419066 | VST44SF TK AIM 1011 |
| 03700712419059 | VST40DF TK AIM 08 |
| 03700712419042 | VST40SF TK AIM 11 |
| 03700712415594 | VST64DF VP AIM 0810 |
| 03700712415587 | VST64SF VP AIM 1011 |
| 03700712415570 | VST44DF VP AIM 0810 |
| 03700712415563 | VST44SF VP AIM 1011 |
| 03700712415556 | VST40DF VP AIM 08 |
| 03700712415549 | VST40SF VP AIM 11 |
| 03700712415532 | VST66DF VP AIM 0810 |
| 03700712415525 | VST66SF VP AIM 1011 |
| 03700712415518 | VST60DF VP AIM 08 |
| 03700712415501 | VST60SF VP AIM 11 |
| 03700712420789 | VCS60DF 11 |
| 03700712420536 | VCS40DF 11 |
| 03700712420529 | VCS66DF 0810 |
| 03700712420512 | VCS66SF 1011 |
| 03700712420505 | VCS64DF 0810 |
| 03700712420499 | VCS64SF 1011 |
| 03700712420482 | VCS44DF 0810 |
| 03700712420475 | VCS44SF 1011 |
| 03700712420468 | VCS60DF 08 |
| 03700712420451 | VCS60SF 11 |
| 03700712420444 | VCS40SF 11 |
| 03700712420437 | VCS40DF 08 |
Trademark Results [Volista]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VOLISTA 85488374 4455583 Live/Registered |
Maquet S.A.S 2011-12-06 |
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