FDA.reportPublic FDA data

NA

Primary DI
30845854061446
Brand
NA
Company
Conmed Corporation
Model
0620-030-100
Catalog number
0620-030-100
Device description
Active Laparoscopic Plume Filtration Device
Published
2020-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAZTUBING, NONINVASIVE
NKCTubing/tubing with filter, insufflation, laparoscopic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAZTubing, NoninvasiveGeneral Hospital2
NKCTubing/Tubing With Filter, Insufflation, LaparoscopicObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30845854061446PackageGS110In Commercial Distribution
20845854061449PrimaryGS10
00845854061445Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084585406144630845854061446
2084585406144920845854061449
00845854061445008458540614458458540614450845854061445

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature14 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
10
DM exempt
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10845854051399AirSealiAS8-dViAS8-dV2021-08-22
10845854084137AirSeal®iAS8-dVLiAS8-dVL2023-01-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04573316385353KITAZATO VACUUM LINEKITAZATO CORPORATIONGAZ2026-03-13
14573316385367KITAZATO VACUUM LINEKITAZATO CORPORATIONGAZ2026-03-13
04573316385377KITAZATO VACUUM LINEKITAZATO CORPORATIONGAZ2026-03-13
04573316388538KITAZATO VACUUM LINEKITAZATO CORPORATIONGAZ2026-03-13
00840493412498RIVA Posterior Fixation SystemXENIX MEDICAL LLCNKC2026-02-16
00840493412535RIVA Posterior Fixation SystemXENIX MEDICAL LLCNKC2026-02-16
00849296016865WelmedWELMED INC.GAZ2026-02-15
00849296016872WelmedWELMED INC.GAZ2026-02-15
00849296016889WelmedWELMED INC.GAZ2026-02-15
00849296016896WelmedWELMED INC.GAZ2026-02-15
00849296016902WelmedWELMED INC.GAZ2026-02-15
00849296016919WelmedWELMED INC.GAZ2026-02-15
00849296016926WelmedWELMED INC.GAZ2026-02-15
00849296016933WelmedWELMED INC.GAZ2026-02-15
00849296016940WelmedWELMED INC.GAZ2026-02-15
00849296016957WelmedWELMED INC.GAZ2026-02-15
00849296016964WelmedWELMED INC.GAZ2026-02-15
00849296016971WelmedWELMED INC.GAZ2026-02-15
00849296016988WelmedWELMED INC.GAZ2026-02-15
00849296016995WelmedWELMED INC.GAZ2026-02-15
00849296017008WelmedWELMED INC.GAZ2026-02-15
00849296017015WelmedWELMED INC.GAZ2026-02-15
00849296017022WelmedWELMED INC.GAZ2026-02-15
00849296017039WelmedWELMED INC.GAZ2026-02-15
50885380072350CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-13
10885380172519CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
10885380172526CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
10885380172533CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
10885380172557CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02
10885380172571CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-02