FDA.reportPublic FDA data

DISTAL-END FLUSHING ADAPTER

Primary DI
04953170437915
Brand
DISTAL-END FLUSHING ADAPTER
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-2319
Catalog number
N5993301
Published
2023-04-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K193182000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193182000Evis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp.2020-01-17FDT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170437915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170437915049531704379154953170437915

GMDN Terms#

Term, Definition table
TermDefinition
Luminal device flushing tubing set, reusableA collection of devices which includes connection tubing intended to be fitted to a luminal device (e.g., catheter, endoscope channel, ophthalmic handpiece) to assist flushing the device lumen during a medical/surgical procedure, and/or to assist the washing, disinfection and/or sterilization of the lumen. In addition to tubing, the set includes connectors/valves to allow appropriate fluids (e.g., sterilant, disinfectant) and gases to flow through the device lumen. It may be used in conjunction with a syringe, device washer/disinfector, and/or water tap. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""High-level Disinfectant"", ""Ethylene Oxide""]"
Moist Heat or Steam Sterilization;High-level Disinfectant;Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170158759DISPOSABLE HOT BIOPSY FORCEPSFD-210U2016-09-21
04953170158766DISPOSABLE HOT BIOPSY FORCEPSFD-230U2016-09-21
04953170354236DISPOSABLE HOT BIOPSY FORCEPSFD-210UN53565302016-09-21
04953170354243DISPOSABLE HOT BIOPSY FORCEPSFD-230UN53566302016-09-21
04953170214288RECORDER UNIT HARNESSMAJ-1475N24838302023-06-21
04953170331718Light guideOCS5-LG2016-09-21
04953170333316RECORDER HOLDERMAJ-2033N44720302016-09-21
04953170467592DISPOSABLE BIOPSY FORCEPSFB-211DN54318422026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSFB-221DN54319422026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSFB-231DN54320422026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSFB-241DN54321422026-04-09
04953170466038Single Use Electrosurgical Hemostatic ForcepsFD-410LRN10861412026-04-01
04953170466182Single Use Electrosurgical Hemostatic ForcepsFD-411URN30463402026-04-01
04953170466267Single Use Electrosurgical Hemostatic ForcepsFD-412LRN53686402026-04-01
04953170035647ELECTROSURGICAL SNARESD-5L-12016-09-21
04953170035708ELECTROSURGICAL SNARESD-5U-12016-09-21
04953170035838ELECTROSURGICAL SNARESD-6U-12016-09-21
04953170035951ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170035968ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170036033ELECTROSURGICAL SNARESD-8P-12016-09-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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