MediSourceNet, Inc

Primary DI
00850034735023
Brand
MediSourceNet, Inc
Company
Medisourcenet, Inc
Model
KWV-F
Device description
KWV-F : KwikVac Smoke Evacuation Filter / 1 each
Published
2021-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FYDApparatus, Exhaust, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYDApparatus, Exhaust, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192035000EvaQMax Smoke Evacuation SystemBio Protech, Inc.2019-08-29FYD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850034735020PackageGS14In Commercial Distribution
00850034735023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003473502010850034735020
00850034735023008500347350238500347350230850034735023

GMDN Terms#

Term, Definition table
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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118269952
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850034735160MediSourceNet, IncKWV-StarterKit2023-08-14
00850034735153MediSourceNet, IncMSNCF222022-09-06
00850034735146MediSourceNet, IncP9552F-MSN2022-09-06
10850034735150MediSourceNet, IncMSNCF222022-09-06
00850034735047MediSourceNet, IncREGL2021-08-30
00850034735054MediSourceNet, IncREGLI2021-08-30
00850034735061MediSourceNet, IncREGLI-52021-08-30
00850034735078MediSourceNet, IncREGL-52021-08-30
00850034735085MediSourceNet, IncEXTL2021-08-30
00850034735092MediSourceNet, IncEXTLI2021-08-30
00850034735108MediSourceNet, IncEXTL-52021-08-30
00850034735115MediSourceNet, IncEXTLI-52021-08-30
00850034735122MediSourceNet, IncWELF2021-08-30
00850034735139MediSourceNet, IncWELF-52021-08-30
00850034735009MediSourceNet, IncKWV-M2021-08-30
00850034735016MediSourceNet, IncKWV-DT2021-08-30
00850034735030MediSourceNet, IncKWV-LT2021-08-30
10850034735044MediSourceNet, IncREGL2021-08-30
10850034735051MediSourceNet, IncREGLI2021-08-30
10850034735068MediSourceNet, IncREGLI-52021-08-30

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