FDA.reportPublic FDA data

IRRI-FLO II

Primary DI
00821925036130
Brand
IRRI-FLO II
Company
Gyrus ACMI, LLC
Model
5920002BX
Device description
IRRI-FLO II Irrigation Delivery System (5/PK)
Published
2024-07-24
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K891339000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K891339000IRRI-FLO IRRIGATION DELIVERY SYSTEMSurgitek1989-06-02OCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925009332PackageGS15In Commercial Distribution
00821925036130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925009332008219250093328219250093320821925009332
00821925036130008219250361308219250361300821925036130

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.

Regulatory Flags#

DUNS number
007198742
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925013964GYRUS ACMI, INC1400032015-10-24
00821925014039EVONOS GMBH & Co. Kg1400532015-10-24
00821925014060EVONOS GMBH & Co. Kg1400592015-10-24
00821925014176GYRUS ACMI, INC1400872015-10-24
00821925014190GYRUS ACMI, INC1401022015-10-24
00821925014497GYRUS ACMI, INC1401032015-10-24
00821925014534GYRUS ACMI, INC1400702015-10-24
00821925015449Gyrus ACMI1401812015-10-24
00821925015470Gyrus ACMI1401852015-10-24
00821925015487Gyrus ACMI1401862015-10-24
00821925015500GYRUS ACMI, INC1401882015-10-24
00821925016057Gyrus ACMI1401642015-10-24
00821925016064Gyrus ACMI1401652015-10-24
00821925016071Gyrus ACMI1401662015-10-24
00821925016088Gyrus ACMI1401672015-10-24
00821925016095GYRUS ACMI, INC1401682015-10-24
00821925016125Gyrus ACMI1401802015-10-24
00821925016934GYRUS ACMI, INC1401492015-10-24
00821925016965Gyrus ACMI1401622015-10-24
00821925017207GYRUS ACMI, INC1401082015-10-24

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Primary DI, Brand, Company table
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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