FDA.reportPublic FDA data

ELUXEO Tubing Kit

Primary DI
03700506320271
Brand
ELUXEO Tubing Kit
Company
NISSHA MEDICAL TECHNOLOGIES SAS
Model
35841703
Device description
DUO TUBING + CO2 INSUFFLATION TUBING - FUJIFILM GI ENDOSCOPES 700 SERIES /LUER CONNECTION - STERILE
Published
2024-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OCXEndoscopic Irrigation/Suction System

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
13700506320278PackageGS110In Commercial Distribution
03700506320271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1370050632027813700506320278
03700506320271037005063202713700506320271

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation tubing set, single-useA collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit122 Degrees Fahrenheit

Regulatory Flags#

DUNS number
391906658
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
03700506318940INTEGRAL PROCESS Cables & Leadwires72473-US2022-12-22
03700506319480INTEGRAL PROCESS Cables & Leadwires70612GEJ5T-US2022-12-22
03700506304653INTEGRAL PROCESS Cables & Leadwires72191-US2024-02-23
03700506319046INTEGRAL PROCESS Cables & Leadwires72191-US-3.50M2024-02-23
03700506319466INTEGRAL PROCESS Cables & Leadwires70612SJ5T-US2024-01-19
03700506320189INTEGRAL PROCESS Cables & Leadwires71041-US-5.5M2023-04-19
03700506320196INTEGRAL PROCESS Cables & Leadwires72350-US-5.5M2023-04-19
03700506303601INTEGRAL PROCESS Cables & Leadwires70611NGJ3-US2023-02-23
03700506303625INTEGRAL PROCESS Cables & Leadwires70611NGJ5-US2023-02-23
03700506303700INTEGRAL PROCESS Cables & Leadwires70612NGJ5-US2023-02-23
03700506303809INTEGRAL PROCESS Cables & Leadwires70618NGJ3-US2023-02-23
03700506304349INTEGRAL PROCESS Cables & Leadwires71780-US2023-02-23
03700506304790INTEGRAL PROCESS Cables & Leadwires72465-US2023-02-23
03700506304813INTEGRAL PROCESS Cables & Leadwires72466-US2023-02-23
03700506311422INTEGRAL PROCESS Cables & Leadwires72465S-US2023-02-23
03700506312924INTEGRAL PROCESS Cables & Leadwires70610NGJ5-US2023-02-23
03700506318902INTEGRAL PROCESS Cables & Leadwires72712-US2023-02-23
03700506318919INTEGRAL PROCESS Cables & Leadwires72711-US2023-02-23
03700506319176INTEGRAL PROCESS Cables & Leadwires71780S-US2023-02-23
03700506319459INTEGRAL PROCESS Cables & Leadwires70612SJ5-US2023-02-23

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Primary DI, Brand, Company table
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08809327356188ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356195ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
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M710TCW51000Bayou™ troCarWash System Disposable KitBIOTEX, INC.OCX2025-10-10
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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
03700506320288ELUXEO TubingNISSHA MEDICAL TECHNOLOGIES SASOCX2024-09-02
03700506320295ELUXEO TubingNISSHA MEDICAL TECHNOLOGIES SASOCX2024-09-02
03700506320301ELUXEO TubingNISSHA MEDICAL TECHNOLOGIES SASOCX2024-09-02