DEVICE: Bayou™ troCarWash System Controller (M710TCWC0)
Device Identifier (DI) Information
Bayou™ troCarWash System Controller
TCW-C
In Commercial Distribution
BIOTEX, INC.
TCW-C
In Commercial Distribution
BIOTEX, INC.
No description.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 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.
|
Active | false |
| 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).
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| OCX | Endoscopic Irrigation/Suction System |
| FEQ | Pump, Air, Non-Manual, For Endoscope |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Humidity: between 20 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature: between -28 and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
| Handling Environment Humidity: between 20 and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature: between 0 and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
f018579e-4172-486e-a889-05ef4bcfba17
August 13, 2024
2
January 22, 2024
August 13, 2024
2
January 22, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
7137410111
xx@xx.xx
xx@xx.xx