FDA.reportPublic FDA data

ViroSafe

Primary DI
20851136002192
Brand
ViroSafe
Company
Buffalo Filter
Model
Kit
Catalog number
VSEY1-4
Device description
Erbium YAG Filter 00851136002181 and four Erbium YAG Pre-filters 00851136002715
Published
2018-07-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K983298000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983298000BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PFBuffalo Filter Co., Inc.1999-08-16FYD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20851136002192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2085113600219220851136002192

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
787855907
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815198011031Buffalo FilterVT106102016-10-05
00815198011055Buffalo FilterVTWT4062016-09-30
00815198011086Buffalo FilterVT104052016-09-30
00815198011284Buffalo FilterVTWT2062016-09-30
00815198012519PenAdaptPA2010BCB2016-09-23
00815198012663Buffalo Filter777-007A2016-10-05
00815198012717InvuityPB1SEPB1SE2018-07-12
00815198012762OR-VACSEOOLLAP122018-07-12
00815198012779OR-VACOL3MT24OL3MT242018-07-12
00851136002068Buffalo FilterVTWT6242016-09-30
00851136002105Buffalo FilterVTWT4242016-09-30
00851136002143PenAdaptPA20102016-09-23
00851136002150Buffalo FilterVT103242016-10-05
00851136002174Buffalo FilterVT104242016-09-30
00851136002228PenAdaptPA2010CB2016-09-23
00851136002235Buffalo FilterVTVIC102016-09-30
00851136002266Buffalo FilterVT106242016-09-30
00851136002334Buffalo FilterPSFTS05PSFTS052017-01-06
00851136002358Buffalo FilterRF102102016-09-30
00851136002372PenAdaptPA1025CBPA1025CB2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10860012888815Flamingo Funnel (microSQUAIR) - MediumNASCENT SURGICAL, LLCFYD2026-05-01
10860012888822Flamingo Funnel (nanoSQUAIR) - Small NASCENT SURGICAL, LLCFYD2026-05-01
20845854081751CONMED BUFFALO FILTERConmed CorporationFYD2024-03-25
10193489085341MedlineMEDLINE INDUSTRIES, INC.FYD2023-02-22
10193489085358MedlineMEDLINE INDUSTRIES, INC.FYD2023-02-22
10845854600085Smoke Shark IIIConmed CorporationFYD2021-02-12
10845854600092Smoke Shark IIIConmed CorporationFYD2021-02-12
20845854600105Smoke Shark IIIConmed CorporationFYD2021-01-20
40845854081830VIROSAFEConmed CorporationFYD2021-01-20
10845854082898BOVIE SharkSkinConmed CorporationFYD2021-01-07
40845854053127MEGADYNE MICROSAFEConmed CorporationFYD2020-12-08
10845854053096MINIVACConmed CorporationFYD2020-11-20
10845854053102MINIVACConmed CorporationFYD2020-11-20
20845854082802VIROSAFEConmed CorporationFYD2020-11-02
20845854081775OR-VACConmed CorporationFYD2020-10-23
20845854081058OR-VACConmed CorporationFYD2020-10-21
30845854081024OR-VACConmed CorporationFYD2020-10-21
30845854081031OR-VACConmed CorporationFYD2020-10-21
30845854081048OR-VACConmed CorporationFYD2020-10-21
30845854081680NAConmed CorporationFYD2020-10-14
20845854081706BOWAConmed CorporationFYD2020-09-30
20845854053192PENADAPTConmed CorporationFYD2020-09-17
20845854061814BOWAConmed CorporationFYD2020-09-15
20845854061821BOWAConmed CorporationFYD2020-09-15
20845854060015VIROSAFEConmed CorporationFYD2020-09-13
20845854081805HarmonyAIRConmed CorporationFYD2020-09-11
30845854053182BOWAConmed CorporationFYD2020-09-05
10614559104521MegadyneMEGADYNE MEDICAL PRODUCTS, INC.FYD2020-09-02