FDA.reportPublic FDA data

ERBEFLO® 2

Primary DI
04065655000160
Brand
ERBEFLO® 2
Company
Erbe Medical, LLC
Model
20325-212
Catalog number
20325-212
Device description
Endoscopy Port Connector for Pentax® Scopes
Published
2021-12-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
K190469000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190469000ERBEFLO 2 Disposable Tubing SystemErbe USA, Inc.2019-05-23OCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04065655000177PackageGS110In Commercial Distribution
04065655000184PackageGS15In Commercial Distribution
04050147012868PreviousGS10
04065655000160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04065655000177040656550001774065655000177
04065655000184040656550001844065655000184
04050147012868040501470128684050147012868
04065655000160040656550001604065655000160

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length70Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from heat and direct sunlight
Special Storage Condition, Specify00Keep dry

Contacts#

Phone, Email table
PhoneEmail
1-770-955-4400technicalservice@erbe-usa.com

Regulatory Flags#

DUNS number
117862528
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04065655001396ERBEFLO®20325-22520325-2252023-10-11
04065655000436ERBEFLO CleverCap®20325-20620325-2062023-09-22
04065655000603ERBEFLO CleverCap®20325-20120325-2012023-09-22
04065655000689ERBEFLO CleverCap®20325-20720325-2072023-09-22
04065655000887ERBEFLO CleverCap®20325-20920325-2092023-09-22
04065655000917ERBEFLO CleverCap®20325-21920325-2192023-09-22
04065655000948ERBEFLO AeroRinse®20325-23520325-2352023-09-22
04065655000979ERBEFLO AeroRinse®20325-24320325-2432023-09-22
04065655001006ERBEFLO CleverCap®20325-24820325-2482023-09-22
04065655001037ERBEFLO AeroRinse®20325-23620325-2362023-09-22
04065655001068ERBEFLO AeroRinse®20325-23720325-2372023-09-22
04065655001099ERBEFLO CleverCap®20325-20820325-2082023-09-22
04065655001150ERBEFLO CleverCap®20325-20220325-2022023-09-22
04065655001211ERBEFLO CleverCap®20325-20320325-2032023-09-22
04065655001242ERBEFLO AeroRinse®20325-23220325-2322023-09-22
04065655001273ERBEFLO AeroRinse®20325-23320325-2332023-09-22
04065655001303ERBEFLO CleverCap®20325-20520325-2052023-09-22
04065655001365ERBEFLO AeroRinse®20325-23120325-2312023-09-22
04065655000375ERBEFLO CleverCap®20325-23920325-2392023-09-22
04065655000405ERBEFLO CleverCap®20325-24020325-2402023-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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08809327356133ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356140ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
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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