FDA.report

NA

Primary DI
30845854081673
Brand
NA
Company
Conmed Corporation
Model
MH100016
Catalog number
MH100016
Device description
smokeStar 220/240V
Published
2020-10-14
Public version status
New
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
30845854081673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3084585408167330845854081673

GMDN Terms

TermDefinition
Surgical plume evacuation systemA mains electricity (AC-powered) assembly of devices intended to capture smoke generated during open surgical procedures involving tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). It captures the plume (smoke composed of carbonized cell fragments, water vapour, and hydrocarbons from vaporized tissue) near its origin before it becomes dispersed and causes surgical staff respiratory exposure. It consists of a capture tube or wand and four elements to evacuate smoke: user interface, filters, suction source, and exhaust. The system may be mobile (on wheels) and used during closed surgical procedures (e.g., endoscopy, laparoscopy) to clear the view. See also: Gas/fume evacuation system; Anaesthetic gas scavenging unit; Suction system filter, plume particulate; Orthopaedic cement fume evacuator; Surgical plume evacuation system tube

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00KEEP DRY
Storage Environment Atmospheric Pressure0.5 KiloPascal1.06 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866)426-6633CustomerExperience@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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
20653405037573CONMEDPCD10PCD102016-09-24
10653405063797CONMED75200752002026-03-24
00845854035590CONCEPTESA-5190ESA-51902026-03-24
10845854041116POWERPROPRO2000PRO20002026-03-24
10845854041291CONMEDLS7501LS75012026-03-24
00653405014952POOLE903507090350702026-03-24
20653405017759CONMEDD8324D83242026-03-24
20653405017766CONMEDD8324IID8324II2026-03-24
20653405019777CONMEDDA36-03DA36-032026-03-24
20653405022821CONMEDFSR1303FSR13032026-03-24
20653405022838CONMEDFSR1311FSR13112026-03-24
20653405022951CONMEDFSR1370FSR13702026-03-24
20653405023057CONMEDFSR1534FSR15342026-03-24
20653405023071CONMEDFSR1539FSR15392026-03-24
20653405023163CONMEDFSR1590FSR15902026-03-24
20653405023170CONMEDFSR1590-20FSR1590-202026-03-24
20653405023385CONMEDFSR380FSR3802026-03-24
20653405023545CONMEDFSR565FSR5652026-03-24
20653405024948CONMEDR324IIRA2R324IIRA22026-03-24
20653405034701CONMEDD8550D85502026-03-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10705036046523MegadyneMEGADYNE MEDICAL PRODUCTS, INC.FYD2025-06-18
30653405990196PlumeSafe® X5™Conmed CorporationFYD2024-08-13
10653405987550PlumeSafe® X5™Conmed CorporationFYD2024-08-12
10653405987994PlumeSafe® X5™Conmed CorporationFYD2024-08-12
10653405988007PlumeSafe® X5™Conmed CorporationFYD2024-08-12
30653405987561PlumeSafe® X5™Conmed CorporationFYD2024-08-12
30653405988018PlumeSafe® X5™Conmed CorporationFYD2024-08-12
00845854081757CooperSurgicalConmed CorporationFYD2024-03-25
00845854081641PLUMEGUARDConmed CorporationFYD2023-12-05
00845854081924CONMEDConmed CorporationFYD2023-12-05
30845854053106MINIVACConmed CorporationFYD2023-12-01
00845854080965CONMEDConmed CorporationFYD2023-12-01
30845854081147CYNOSUREConmed CorporationFYD2023-06-16
00817688021902Crystal VisionI.C. MEDICAL, INC.FYD2023-03-06
30193489085345MedlineMEDLINE INDUSTRIES, INC.FYD2023-02-22
20193489085355MedlineMEDLINE INDUSTRIES, INC.FYD2023-02-22
00817183020660NEBULAE SRS Tubing SetNORTHGATE TECHNOLOGIES INC.FYD2023-02-14
00817183020684NEBULAE SRS Laparoscopic Surgical PumpNORTHGATE TECHNOLOGIES INC.FYD2023-02-14
00840319734520Hayden MedicalHayden Medical, Inc.FYD2022-09-12
00840319734537Hayden MedicalHayden Medical, Inc.FYD2022-09-12
10653405002543NAConmed CorporationFYD2022-06-02
30653405988124Foot switch for FUMOVAC 900Conmed CorporationFYD2022-03-30
20845854082543Pneumatic Footswitch for PlumeVac™ Smoke Plume EvacuatorConmed CorporationFYD2021-12-20
30845854081116CYNOSUREConmed CorporationFYD2021-11-26
10845854648599TeleVac2Conmed CorporationFYD2021-11-08
30653405987622OR-VACConmed CorporationFYD2021-10-27
00817688022978STERISI.C. MEDICAL, INC.FYD2021-10-19
00817688022985STERISI.C. MEDICAL, INC.FYD2021-10-19
00817688023005STERISI.C. MEDICAL, INC.FYD2021-10-19
00817688023012STERISI.C. MEDICAL, INC.FYD2021-10-19