FDA.reportPublic FDA data

Zutron Medical

Primary DI
00817658021659
Brand
Zutron Medical
Company
ZUTRON MEDICAL, L.L.C.
Model
ZUTR50523
Catalog number
ZUTR50523
Device description
Check valve, normally closed, non-sterile
Published
2023-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
K181509000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181509000Endorate Valve SetsSmartdata Suzhou Co., Ltd.2018-07-06OCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817658021666PackageGS1100Not in Commercial Distribution
00817658021659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817658021666008176580216668176580216660817658021666
00817658021659008176580216598176580216590817658021659

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.

Contacts#

Phone, Email table
PhoneEmail
8773435873xx@xx.xx

Regulatory Flags#

DUNS number
962532441
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
00817658022007Zutron MedicalEndo Leak TesterZUTR300052023-09-21
00817658023790Zutron MedicalEndo Leak TesterZUTR10005A2023-09-21
00817658023806Zutron MedicalEndo Leak TesterZUTR10005CA2023-09-21
00817658023813Zutron MedicalEndo Leak TesterZUTR10005F2023-09-21
00817658023837Zutron MedicalEndo Leak TesterZUTR10005HH2023-09-21
00817658023844Zutron MedicalEndo Leak TesterZUTR10005O2023-09-21
00817658023868Zutron MedicalEndo Leak TesterZUTR10005P2023-09-21
00817658023875Zutron MedicalEndo Leak TesterZUTR10005S2023-09-21
00817658023882Zutron MedicalEndo Leak TesterZUTR10005W2023-09-21
10817658023216Zutron MedicalEndoscopy Procedure KitZUTR401112023-07-28
10817658023285Zutron MedicalEndoscopy Procedure KitZUTRMNGI2023-07-28
10817658023315Zutron MedicalEndoscopy Procedure KitZUTR401162023-07-28
10817658023353Zutron MedicalEndoscopy Procedure KitZUTR401232023-07-28
00817658020003Zutron MedicalEndoscopy Procedure KitZUTR400012016-12-01
00817658020072Zutron MedicalEndoscopy Procedure KitZUTR400032023-07-28
00817658020102Zutron MedicalEndoscopy Procedure KitZUTR40004 2023-07-28
00817658020133Zutron MedicalEndoscopy Procedure KitZUTR400082023-07-28
00817658020270Zutron MedicalEndoscopy Procedure KitZUTR401032023-07-28
00817658020348Zutron MedicalEndoscopy Procedure KitZUTR40008DBL2023-07-28
00817658020409Zutron MedicalEndoscopy Procedure KitZUTR400112023-07-28

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