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Bayou™ troCarWash System Disposable Kit
FDA UDIClass II (US FDA UDI)
by Biotex, Inc.
Identity
- Trade Name
- Bayou™ troCarWash System Disposable Kit FDA UDI
- Generic Name
- Endoscope lens cleaner, gas/fluid, single-use FDA UDI
- Model / Reference
- 038-1000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M71003810000 FDA UDI
- 510(k) Number
- K222695 FDA UDI
- FDA Product Code
- OCX FDA UDIFEQ FDA UDI
- GMDN Term
- Endoscope lens cleaner, gas/fluid, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
A comprehensive 2-3 paragraph SEO description written in clear, natural language. The Bayou troCarWash System Disposable Kit is a disposable endoscope lens cleaner, designed 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. This single-use device is intended for implantable use.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biotex, Inc.
Sources (1)
- FDA UDI 39d107c8-cd3e-4ce7-92e5-7839000a1de5 36 fields · synced Jul 21, 2026