PlumeSafe® X5™ PX5-135-22
GUDID 10653405987994
Filter, 7/8” (22 mm), 3/8” (9.5 mm), 7/8” (22 mm) Ports
Conmed Corporation
Surgical plume evacuation system filter| Primary Device ID | 10653405987994 |
| NIH Device Record Key | 6330d7ad-9fa1-4ff2-8f6c-fd48cca0dbf3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PlumeSafe® X5™ |
| Version Model Number | PX5-135-22 |
| Catalog Number | PX5-135-22 |
| Company DUNS | 071595540 |
| Company Name | Conmed Corporation |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| Serial Number | false |
| 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 |
Customer Support Contacts
| 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 | |
| Phone | +1(866)426-6633 |
| CustomerExperience@conmed.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -29.2 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -29.2 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -29.2 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -29.2 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -29.2 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -29.2 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -29.2 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -29.2 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -29.2 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -29.2 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -29.2 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -29.2 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -29.2 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -29.2 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -29.2 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -29.2 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Temperature | Between -29.2 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10653405987994 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K240127
FDA Product Code
| FYD | APPARATUS, EXHAUST, SURGICAL |
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 | 2024-08-20 |
| Device Publish Date | 2024-08-12 |
On-Brand Devices [PlumeSafe® X5™]
| 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 |
Trademark Results [PlumeSafe]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PLUMESAFE 74308549 1768545 Live/Registered |
BUFFALO FILTER LLC 1992-08-28 |
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