FDA.reportPublic FDA data

Clean Connecting Tube

Primary DI
06936603225530
Brand
Clean Connecting Tube
Company
Yangzhou Fartley Medical Instrument Technology Co., Ltd
Model
FTL-EFC-F700-H2-F
Published
2024-01-30
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
06936603225530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936603225530069366032255306936603225530

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
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
06936603227718HemoclipFTL-HC-09-230-OMMC-230-092026-01-26
16936603227715HemoclipFTL-HC-09-230-OMMC-230-092026-01-26
06936603228937Single Use Angulation Knob ExtenderFTL-DEK-AMAJ-22192025-12-03
06936603231739Single-Use ErgoGrip Knob ExtenderFTL-DEK-BMAJ-22262025-12-03
16936603228934Single Use Angulation Knob ExtenderFTL-DEK-AMAJ-22192025-12-03
16936603231736Single-Use ErgoGrip Knob ExtenderFTL-DEK-BMAJ-22262025-12-03
06936603226902Disposable Endoscopy Valve SetFTL-VS-PI20-J1152812025-08-21
16936603226909Disposable Endoscopy Valve SetFTL-VS-PI20-J1152812025-08-21
06936603210567Disposable Endoscopy Valve SetFTL-VS-PI20-A1152822024-03-08
06936603216460Disposable Endoscopy Adapter SetsFTL-VS-P-A1152922024-03-08
06936603216477Disposable Endoscopy Adapter SetsFTL-VS-P-B11152932024-03-08
06936603216491Disposable Endoscopy Adapter SetsFTL-VS-P-K11152942024-03-08
06936603224403Disposable Endoscopy Valve SetFTL-VS-PI20-B1152832024-03-08
06936603224410Disposable Endoscopy Valve SetFTL-VS-PI20-C1152842024-03-08
06936603227947Single Use Cleaning BrushFTL-CB-EBAK200000182025-07-07
16936603227944Single Use Cleaning BrushFTL-CB-EBAK200000182025-07-07
06936603230862Bedside Cleaning SpongeFTL-BCS-S1-BZ-WSEN-BK-12025-06-23
06936603230879Basic Bedside KitFTL-IPK-GSEN-BK-22025-06-23
06936603230886Basic Bedside KitFTL-IPK-HSEN-BK-32025-06-23
06936603230893Basic Bedside KitFTL-IPK-ISEN-BK-42025-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
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
00850025860840Irrigation Tubing SetMicro-tech UsaOCX2025-03-04
00850025860307A/W Channel Cleaning Adapter + 4-Piece Valve KitMicro-tech UsaOCX2025-03-03
008500258603694-Piece Valve KitMicro-tech UsaOCX2025-03-03
008500258605813-Piece Valve KitMicro-tech UsaOCX2025-03-03
00858276007243Jacket Biopsy ValveMicro-tech UsaOCX2025-03-03
00858276007335Jacket Biopsy ValveMicro-tech UsaOCX2025-03-03
M78312011110Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.OCX2025-01-10
03700506320264ELUXEO Tubing KitNISSHA MEDICAL TECHNOLOGIES SASOCX2024-09-02
03700506320271ELUXEO Tubing KitNISSHA MEDICAL TECHNOLOGIES SASOCX2024-09-02
03700506320288ELUXEO TubingNISSHA MEDICAL TECHNOLOGIES SASOCX2024-09-02
03700506320295ELUXEO TubingNISSHA MEDICAL TECHNOLOGIES SASOCX2024-09-02