| Primary Device ID | 30653405987592 |
| NIH Device Record Key | dee32fdc-0547-4d41-a618-3f8194bb025c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PlumeSafe® X5™ |
| Version Model Number | PX5-220P1 |
| Catalog Number | PX5-220P1 |
| Company DUNS | 071595540 |
| Company Name | Conmed Corporation |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 30653405987592 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-22 |
| Device Publish Date | 2024-10-14 |
| 30653405988018 | Filter, 1” (25 mm), 3/8” (9.5 mm), 1” (25 mm) Ports |
| 30653405987561 | Smoke Evacuation Unit |
| 10653405988007 | Filter, 1” (25 mm), 3/8” (9.5 mm), 1” (25 mm) Ports |
| 10653405987994 | Filter, 7/8” (22 mm), 3/8” (9.5 mm), 7/8” (22 mm) Ports |
| 10653405987550 | Smoke Evacuation Unit with PlumeSafe X5 Smoke Evacuation Filter |
| 30653405990196 | Filter, 7/8” (22 mm), 3/8” (9.5 mm), 7/8” (22 mm) Ports |
| 30653405990141 | PlumeSafe® X5™ Smoke Evacuation Unit with PlumeSafe® X5™ Smoke Evacuator Filter, 220V-240V |
| 30653405987608 | PlumeSafe® X5™ Smoke Evacuation Unit, 220V-240V 50/60 Hz |
| 30653405987592 | PlumeSafe® X5™ Smoke Evacuation Unit with PlumeSafe® X5™ Smoke Evacuator Filter, 220V-240V |
| 30653405987585 | PlumeSafe® X5™ Smoke Evacuation Unit, 220V-240V 50/60 Hz |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PLUMESAFE 74308549 1768545 Live/Registered |
BUFFALO FILTER LLC 1992-08-28 |