Identity
- Trade Name
- BioGuard FDA UDI
- Generic Name
- Endoscope channel support kit FDA UDI
- Device Name
- The BioGuard valves (4-piece) and air/water cleaning adapter kit is used to control the suction function of an endoscope during GI endoscopic procedures. The single use BioShield biopsy valve is used to cover the opening to the biopsy/suction channel of Olympus and G5 and newer Fujinon gastrointestinal endoscopes. The Torrent irrigation scope connector is used in conjunction with the Torrent irrigation tubing. 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
- 00711787 FDA UDI
- Description
- The BioGuard valves (4-piece) and air/water cleaning adapter kit is used to control the suction function of an endoscope during GI endoscopic procedures. The single use BioShield biopsy valve is used to cover the opening to the biopsy/suction channel of Olympus and G5 and newer Fujinon gastrointestinal endoscopes. The Torrent irrigation scope connector is used in conjunction with the Torrent irrigation tubing. 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
- 00711787 FDA UDI
- Primary DI / UDI-DI
- 00724995180584 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: Endoscopic insufflation tubing set, single-useEndoscope channel support kitEndoscope working-channel valve, single-use
BioGuard by US Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endoscope working-channel valve, single-use.
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- Edge — Covidien LP · Class II
- SINGLE USE BIOPSY VALVE (Sterile) — Olympus Medical Systems Corporation · Class II
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 c5c74d12-79d8-48ce-b2dd-07b421616430 36 fields · synced May 30, 2026