FDA.reportPublic FDA data

Bayou™ troCarWash System Disposable Kit

Primary DI
M710TCW51000
Brand
Bayou™ troCarWash System Disposable Kit
Company
BIOTEX, INC.
Model
TCW-5-100
Published
2025-10-10
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FEQPump, Air, Non-Manual, For Endoscope
OCXEndoscopic Irrigation/Suction System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEQPump, Air, Non-Manual, For EndoscopeGastroenterology, Urology2
OCXEndoscopic Irrigation/Suction SystemGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233442000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233442000troCarWash™ SystemBiotex, Inc.2024-05-21OCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M710TCW51000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope lens cleaner, gas/fluid, single-useA sterile device intended to be used for the in situ removal of fog/blood/debris from the lens of an endoscope (e.g., laparoscope), by directing gas and/or liquid to the edge of the lens. It is typically a multichannel sleeve with connection tubing. Gases/fluids are intended to be directed from a source through the channels within the sleeve to the lens. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length100Millimeter
Outer Diameter5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-28 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
7137410111xx@xx.xx

Regulatory Flags#

DUNS number
969792050
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M710TCW101200Bayou™ troCarWash System Disposable KitTCW-10-1202024-01-31
M71004614002Slide Bite Fork046-1400046-14002025-02-28
M710NDK2Safe-Cam Tablet and Accessories033-5000SC-NDK2018-07-25
M710SCC0Safe-Cam Connecting Cable Assembly033-6500SC-C2018-07-25
M710SCM0Safe-Cam Display Monitor Assembly033-6501SC-M2018-07-25
M710SCMR0Safe-Cam Display Monitor Charger033-6000-003SC-MR2018-07-25
M710SCVS0Safe-Cam Sterile Video Stylet033-1000SC-VS2018-07-25
M710TCWC0Bayou™ troCarWash System ControllerTCW-C2024-01-22
M710WW1D0Wire Watch™WW-1D2024-07-03
M710ERGUIDE10050OcciGuide048-1001ER GUIDE 10052021-02-25
M710ERGUIDE10100OcciGuide048-1000ER GUIDE 10102021-02-25
M710ERGUIDE1010OcciGuideER GUIDE 1010048-10002020-02-20
M71003810000Bayou™ troCarWash System Disposable Kit038-10002023-08-04
M71003850000Bayou™ troCarWash System Controller038-50002023-08-04
M710WW12K0Wire Watch™WW-12K2023-07-31
M71002110010Wire Watch™021-10012023-02-09
M71004615000The Slide®046-15002023-05-19
M71004610000The Slide®046-10002021-09-01
M710ERGUIDE10102OcciGuide048-1000ER GUIDE 10102021-02-25
M710ERGUIDE10052OcciGuide048-1001ER GUIDE 10052021-02-25

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Primary DI, Brand, Company table
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08809327356164ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
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08809327356188ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356195ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
M84921890CleanCapture Aspiration CatheterHOBBS MEDICAL, INC.OCX2026-01-14
14953170458429SINGLE USE BIOPSY VALVEOLYMPUS MEDICAL SYSTEMS CORP.OCX2025-09-30
00724995232177Fuji 700 4-piece Valve KitUS EndoscopyOCX2025-05-29
M78312011110Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.OCX2025-01-10
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00724995224189EndoGator HybridMEDIVATORS INC.OCX2024-05-29
00724995224202EndoGator HybridMEDIVATORS INC.OCX2024-05-29
00724995224226EndoGator HybridMEDIVATORS INC.OCX2024-05-29
40677964030985ENDOGATORMEDIVATORS INC.OCX2024-02-29
M710TCW101200Bayou™ troCarWash System Disposable KitBIOTEX, INC.FEQ2024-01-31
M710TCWC0Bayou™ troCarWash System ControllerBIOTEX, INC.OCX2024-01-22
M710TCWC0Bayou™ troCarWash System ControllerBIOTEX, INC.FEQ2024-01-22
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00724995228958DEFENDOMEDIVATORS INC.FEQ2024-01-18
00724995228965DEFENDOMEDIVATORS INC.FEQ2024-01-18
00724995227340NAUS EndoscopyFEQ2023-11-13