FDA.report

Buffalo Filter

Primary DI
30845854080867
Brand
Buffalo Filter
Company
Conmed Corporation
Model
VTESU05
Catalog number
VTESU05
Device description
Smoke Evacuation Tubing 7/8 in (22mm) x 6 ft (1.8m) with 7/8 in (22mm) to 1/4 in (6.4mm) reducer to 1.4 in (6.4mm) x 2 ft (.6m) tubing
Published
2020-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GAZTUBING, NONINVASIVE

Product Code Classifications

CodeDeviceSpecialtyClass
GAZTubing, NoninvasiveGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30845854080867PackageGS15In Commercial Distribution
00851136002464PreviousGS10
20845854080860PrimaryGS10
00845854080866Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3084585408086730845854080867
00851136002464008511360024648511360024640851136002464
2084585408086020845854080860
00845854080866008458540808668458540808660845854080866

GMDN Terms

TermDefinition
Surgical plume evacuation system tubeA sterile, long, hollow cylinder which, as part of a surgical smoke evacuation system, is used to capture and conduct to exhaust the plume generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device.

Sterilization Methods

Method
Radiation Sterilization

Contacts

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

Regulatory Flags

DUNS number
071595540
Device count
5
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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