DEVICE: MEGADYNE (10614559104552)
Device Identifier (DI) Information
MEGADYNE
2550J
In Commercial Distribution
2550J
MEGADYNE MEDICAL PRODUCTS, INC.
2550J
In Commercial Distribution
2550J
MEGADYNE MEDICAL PRODUCTS, INC.
Megadyne MESE1 Smoke Evacuator Filter
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).
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FYD | APPARATUS, EXHAUST, SURGICAL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K200250 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 5 and 50 Degrees Celsius |
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
e9327594-51bb-42d7-a0b0-1316478bd681
July 31, 2023
5
August 03, 2020
July 31, 2023
5
August 03, 2020
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 |
---|---|
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
[?]
No Customer Contact currently defined