FDA.reportPublic FDA data

Clean Connecting Tube

Primary DI
06936603231180
Brand
Clean Connecting Tube
Company
Yangzhou Fartley Medical Instrument Technology Co., Ltd
Model
FTL-EFC-O-S-B1
Catalog number
SEN-INT-O
Device description
Sentrus Insufflation Tubing, Irrigation tubing without CO2 connection (Olympus)
Published
2025-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
OCXEndoscopic Irrigation/Suction System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCXEndoscopic Irrigation/Suction SystemGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220785000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220785000Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., Ltd.2022-09-27OCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16936603231187PackageGS110In Commercial Distribution
06936603231180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693660323118716936603231187
06936603231180069366032311806936603231180

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic insufflation tubing set, single-useA collection of flexible tubing intended to channel medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.

Regulatory Flags#

DUNS number
544375774
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936603211571Disposable Polypectomy SnareFTL-PS-24-230-30-M-NSMO-E24-6-12-30-2302026-10-25
06936603211588Disposable Polypectomy SnareFTL-PS-24-230-30-ACM-NSMO-EA24-6-12-30-2302026-10-25
06936603211595Disposable Polypectomy SnareFTL-PS-24-230-30-M-RSMO-24-6-12-30-2302026-10-25
06936603211618Disposable Polypectomy SnareFTL-PS-24-230-30-MT-RSMO-T24-6-12-30-2302026-10-25
06936603211663Disposable Polypectomy SnareFTL-PS-24-230-10-O-RSOV-DR-24-10-2302026-10-25
06936603211670Disposable Polypectomy SnareFTL-PS-24-230-15-O-RSOV-DR-24-15-2302026-10-25
06936603211687Disposable Polypectomy SnareFTL-PS-24-230-20-O-RSOV-DR-24-20-2302026-10-25
06936603211694Disposable Polypectomy SnareFTL-PS-24-230-25-O-RSOV-DR-24-25-2302026-10-25
06936603211700Disposable Polypectomy SnareFTL-PS-24-230-30-O-RSOV-DR-24-30-2302026-10-25
06936603211731Disposable Polypectomy SnareFTL-PS-24-230-15-O-NSOV-DS-23-15-2302026-10-25
06936603211748Disposable Polypectomy SnareFTL-PS-24-230-20-O-NSOV-DS-23-20-2302026-10-25
06936603211755Disposable Polypectomy SnareFTL-PS-24-230-25-O-NSOV-DS-23-25-2302026-10-25
06936603211779Disposable Polypectomy SnareFTL-PS-24-230-35-O-NSOV-DS-23-35-2302026-10-25
06936603216187Kirei FlowFTL-VS-O-HVS-KIT-07-OLY2026-10-25
06936603218259CO2 AdapterFTL-EFC-O-COAD-CO2-OUS2026-10-25
06936603235508CO2 AdapterFTL-EFC-O-CORAD-CO2-OUS-R2026-10-25
06936603211625Disposable Polypectomy Cold SnareFTL-PSC-24-230-25-10-RCPS-CR-24-02-10-2302026-10-22
06936603211649Disposable Polypectomy Cold SnareFTL-PSC-24-230-25-10-NCPS-CS-24-02-10-2302026-10-22
06936603211724Disposable Polypectomy SnareFTL-PS-24-230-10-O-NSOV-DS-23-10-2302026-10-22
06936603211908Disposable Biopsy ForcepsFTL-BF-18-180-O-O-RTC11-ECO-S-18-180-SU2026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936603212301Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., LtdOCX2026-10-22
06936603212318Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., LtdOCX2026-10-22
06936603212424Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., LtdOCX2026-10-22
06936603212448Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., LtdOCX2026-10-22
06936603212462Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., LtdOCX2026-10-22
06936603212479Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., LtdOCX2026-10-22
04580826928413PENTAX MedicalPENTAX MEDICAL CORPORATIONOCX2026-08-25
00884450457535C2 CryoBalloon™Merit Medical Systems, Inc.OCX2026-08-17
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08809327356133ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356140ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
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08809327356164ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356171ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356188ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356195ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
M84921890CleanCapture Aspiration CatheterHOBBS MEDICAL, INC.OCX2026-01-14
04953170465277AUXILIARY WATER TUBEOLYMPUS MEDICAL SYSTEMS CORP.OCX2025-12-05
M710TCW51000Bayou™ troCarWash System Disposable KitBIOTEX, INC.OCX2025-10-10
14953170458429SINGLE USE BIOPSY VALVEOLYMPUS MEDICAL SYSTEMS CORP.OCX2025-09-30
00724995232177Fuji 700 4-piece Valve KitUS EndoscopyOCX2025-05-29
00850025860901CO2 Source Tubing Filter Adapter OlympusMicro-tech UsaOCX2025-05-12
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04048551411704NAKarl Storz GmbH & Co. KGOCX2025-03-27
00850025860420Irrigation Tubing SetMicro-tech UsaOCX2025-03-07
00850025860390Air/Water Bottle CO2 TubingMicro-tech UsaOCX2025-03-04
00850025860451Air/Water Bottle TubingMicro-tech UsaOCX2025-03-04
00850025860772Air/Water Bottle TubingMicro-tech UsaOCX2025-03-04
00850025860789Air/Water Bottle CO2 TubingMicro-tech UsaOCX2025-03-04
00850025860796Irrigation Tubing SetMicro-tech UsaOCX2025-03-04