FDA.reportPublic FDA data

NA

Primary DI
20845854045739
Brand
NA
Company
Conmed Corporation
Model
SIM-TUB
Catalog number
SIM-TUB
Device description
STD INSUFFLATION TUBE ST 10/CS
Published
2020-09-22
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
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIFInsufflator, LaparoscopicObstetrics/Gynecology2
NKCTubing/Tubing With Filter, Insufflation, LaparoscopicObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20845854045739PackageGS110In Commercial Distribution
10851885004006PreviousGS10
10845854045732PrimaryGS10
00845854045735Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084585404573920845854045739
1085188500400610851885004006
1084585404573210845854045732
00845854045735008458540457358458540457350845854045735

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula, single-useA single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments; it may additionally be intended for thoracoscopy whereby the valve may not be required. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius32 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
071595540
Device count
10
DM exempt
false
Premarket exempt
false
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
false

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
06972304751404InflaCureSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HIF2026-05-22
16972304751555InflaCureSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HIF2026-05-22
10851885004587AIRSEALConmed CorporationHIF2026-03-21
00840493412498RIVA Posterior Fixation SystemXENIX MEDICAL LLCNKC2026-02-16
00840493412535RIVA Posterior Fixation SystemXENIX MEDICAL LLCNKC2026-02-16
15060120950571Insufflation FilterGVS FILTER TECHNOLOGY UK LTDNKC2025-12-11
26931918171255AllesetGRI Medical & Electronic Technology Co., Ltd.NKC2025-12-09
04711605992053The O R Company - InsufflatOR Tubing SetADVANCED MEDICAL DESIGN CO., LTD.NKC2025-07-28
00860012249954VereSeeFreyja Healthcare, LLCHIF2025-06-18
00860012249916VereSeeFreyja Healthcare, LLCHIF2025-06-16
G465100300AirSurgN InsufflatorSmartsurgn Inc.HIF2025-04-22
04048551067444NAKarl Storz GmbH & Co. KGNKC2025-03-28
04048551326664NAKarl Storz GmbH & Co. KGNKC2025-03-28
04953170467226INSUFFLATION TUBEOLYMPUS MEDICAL SYSTEMS CORP.HIF2025-02-26
04953170467233SUCTION TUBEOLYMPUS MEDICAL SYSTEMS CORP.HIF2025-02-26
05391536920142EVA15PALLIARE LIMITEDHIF2024-07-16
05391536920159EVA15PALLIARE LIMITEDHIF2024-07-16
05391536920913EVA15PALLIARE LIMITEDHIF2024-07-16
05391536920944EVA15PALLIARE LIMITEDHIF2024-07-16
10817183020810PUREPNEUMO Tubing SetNORTHGATE TECHNOLOGIES INC.NKC2024-07-09
04055207070109NARichard Wolf GmbHNKC2024-05-24
06937845500607GTKGuangzhou T.K Medical Instrument Co.,Ltd.HIF2024-05-23
06937845500614GTKGuangzhou T.K Medical Instrument Co.,Ltd.HIF2024-05-23
20845854045630AIRSEALConmed CorporationHIF2024-03-27
06973031299573Insufflation tubeGuangdong Optomedic Technologies, Inc.HIF2024-03-26
06973031299870Insufflation tubeGuangdong Optomedic Technologies, Inc.HIF2024-03-26
06973031299887InsufflatorGuangdong Optomedic Technologies, Inc.HIF2024-03-26
10886874120696NoneINTUITIVE SURGICAL, INC.HIF2024-03-25
06971381251357InsufflatorSCIVITA MEDICAL TECHNOLOGY CO., LTD.HIF2024-02-28
06971381251364InsufflatorSCIVITA MEDICAL TECHNOLOGY CO., LTD.HIF2024-02-28