DEVICE: PlumeSafe® X5™ (30653405988018)
Device Identifier (DI) Information
PlumeSafe® X5™
PX5-1354
In Commercial Distribution
PX5-1354
Conmed Corporation
PX5-1354
In Commercial Distribution
PX5-1354
Conmed Corporation
Filter, 1” (25 mm), 3/8” (9.5 mm), 1” (25 mm) Ports
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
44979 | Surgical plume evacuation system filter |
A screening device designed for use with a surgical smoke evacuation system, to entrap particulates from the plume of smoke created typically through the use of various tissue-burning surgical devices (e.g., laser, electrosurgical diathermy device), to prevent this from exhausting into the ambient air or evacuation tubing/pipeline systems. It will typically have a hydrophobic membrane that retains the particulate/bacterial pathogens through a combination of mechanical, electrostatic, or other means. The device comes in various sizes and designs. This is a reusable device, typically with a limited lifetime (e.g., 5 hours, 20 procedures, or weekly exchange).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FYD | APPARATUS, EXHAUST, SURGICAL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K240127 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Humidity: between 0 and 85 Percent (%) Relative Humidity |
Storage Environment Temperature: between -29.2 and 149 Degrees Fahrenheit |
Storage Environment Temperature: between -34 and 65 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b9e7c513-26fb-42a8-aaee-bd224a83345b
August 20, 2024
1
August 12, 2024
August 20, 2024
1
August 12, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(866)426-6633
CustomerExperience@conmed.com
CustomerExperience@conmed.com