Identity
- Trade Name
- BioGuard FDA UDI
- Generic Name
- Endoscope channel support kit FDA UDI
- Device Name
- The BioGuard valves and air/water cleaning adapter kit is used to control the suction function of an endoscope during GI endoscopic procedures. The BioGuard air/water cleaning adapter is intended as part of the precleaning process to help clear the air/water channel of Olympus GI endoscopes post procedure. FDA UDI
- Model / Reference
- 00711785 FDA UDI
- Description
- The BioGuard valves and air/water cleaning adapter kit is used to control the suction function of an endoscope during GI endoscopic procedures. The BioGuard air/water cleaning adapter is intended as part of the precleaning process to help clear the air/water channel of Olympus GI endoscopes post procedure. FDA UDI
Identifiers
- Catalog Number
- 00711785 FDA UDI
- Primary DI / UDI-DI
- 00724995180560 FDA UDI
- FDA Product Code
- NWU FDA UDI
- GMDN Term
- Endoscope channel support kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscope channel support kitEndoscope air/water valve, single-use
BioGuard by US Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- US Endoscopy
Sources (1)
- FDA UDI 45c15607-1b54-447b-9dbc-aac7ea3c20e4 35 fields · synced May 30, 2026