FDA.reportPublic FDA data

Clean Connecting Tube

Primary DI
16936603231170
Brand
Clean Connecting Tube
Company
Yangzhou Fartley Medical Instrument Technology Co., Ltd
Model
FTL-EFC-F700-D1-B1
Catalog number
SEN-INT-F-CO2
Device description
Sentrus Insufflation Tubing with CO2 Connector, Insufflation tubing with CO2 connection hose (Fuji 700)
Published
2025-06-23
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
false

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
16936603231170PackageGS110In Commercial Distribution
06936603231173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693660323117016936603231170
06936603231173069366032311736936603231173

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544375774
Device count
1
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
true
Sterilization required before use
false

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
B382SD20260Surgical DirectSurgical Direct, Inc.OCX2026-08-03
08809327356133ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356140ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356157ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
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
00858276007977CO2 Source Tubing Filter OlympusMicro-tech UsaOCX2025-05-12
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