FDA.reportPublic FDA data

ERBEFLO AeroRinse®

Primary DI
04065655001280
Brand
ERBEFLO AeroRinse®
Company
Erbe Medical, LLC
Model
20325-233
Catalog number
20325-233
Device description
Air and Water Tubing/Cap Set for Fujinon® Scopes
Published
2023-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

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
K221177000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221177000Erbe's Tubing/Cap SetsErbe USA, Inc.2022-08-11OCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04065655001280PackageGS110In Commercial Distribution
04065655001297PackageGS15In Commercial Distribution
04050147012974PreviousGS10
04065655001273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04065655001280040656550012804065655001280
04065655001297040656550012974065655001297
04050147012974040501470129744050147012974
04065655001273040656550012734065655001273

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic insufflation tubing set, single-useA collection of flexible tubing intended to channel medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0.4Meter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
117862528
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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