FDA.report

PLUMESAFE

Primary DI
10845854061107
Brand
PLUMESAFE
Company
Conmed Corporation
Model
PPS604
Catalog number
PPS604
Device description
Porta PlumeSafe 604 Surgical Smoke Evacuator 100-120V 50/60Hz
Published
2020-06-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FYDAPPARATUS, EXHAUST, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
FYDApparatus, Exhaust, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10845854061107Direct MarkingGS10
00851136002044PreviousGS10
30845854061101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084585406110710845854061107
00851136002044008511360020448511360020440851136002044
3084585406110130845854061101

GMDN Terms

TermDefinition
Surgical plume evacuation system filterA 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).

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM

Regulatory Flags

DUNS number
071595540
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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20653405022951CONMEDFSR1370FSR13702026-03-24
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20653405023071CONMEDFSR1539FSR15392026-03-24
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20653405024948CONMEDR324IIRA2R324IIRA22026-03-24
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