Bayou™ troCarWash System Controller

Basic Information

• Brand Name: Bayou™ troCarWash System Controller
• Primary DI: M71003850000
• Version / Model: 038-5000
• Company Name: BIOTEX, INC.
• Labeler DUNS: 969792050
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-04
• Public Version: 2
• Public Version Date: 2024-01-23
• Public Version Status: Update
• Public Device Record Key: 18ba17fb-0c4e-4f00-b1d2-84de1f9fd67f
• Distribution End Date: 2024-01-22

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	876.1500	2
FEQ	Pump, Air, Non-Manual, For Endoscope	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61204	Endoscope lens cleaner, gas/fluid, single-use	A 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.	No	Active
63646	Surgical irrigation pump	An electrically-powered device, which may include noninvasive accessories, intended to pump a sterile fluid (e.g., saline water) to irrigate body cavities/wounds during surgery (e.g., general surgery, endoscopic). It is typically intended to be used to wash away tissues/fluids/debris with a sterile fluid to facilitate observation; it is not intended to administer parenteral fluids or drugs and is not capable of suction. The device may incorporate a display and may include collection containers or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M71003850000	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K222695	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 20 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -28 – 70 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 20 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 0 – 30 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal