Identity
- Trade Name
- BioGuard FDA UDI
- Generic Name
- Endoscope channel support kit FDA UDI
- Device Name
- The single use BioGuard air/water valve is used to control the air/water function of an endoscope during GI endoscopic procedures. The single use BioGuard suction valve is used to control the suction function of an endoscope during GI endoscopic procedures. FDA UDI
- Model / Reference
- 00711780 FDA UDI
- Description
- The single use BioGuard air/water valve is used to control the air/water function of an endoscope during GI endoscopic procedures. The single use BioGuard suction valve is used to control the suction function of an endoscope during GI endoscopic procedures. FDA UDI
Identifiers
- Catalog Number
- 00711780 FDA UDI
- Primary DI / UDI-DI
- 00816765012772 FDA UDI
- 510(k) Number
- K192059 FDA UDI
- FDA Product Code
- FDF FDA UDIODC 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
- 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
Yes
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
Yes
FDA UDI
BioGuard by US Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 c38745cf-a550-4c5e-8b3f-cfbb036d3497 38 fields · synced May 30, 2026