Identity
- Trade Name
- BioGuard FDA UDI
- Generic Name
- Endoscope working-channel valve, single-use FDA UDI
- Device Name
- The single use BioGuard air/water valve (4-piece) 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. The single use BioShield biopsy valve is used to cover the opening to the biopsy/suction channel of the gastrointestinal endoscope. The BioShield biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port thought the endoscopic procedure and provides access for irrigation. The single use Torrent irrigation scope connector is used in conjunction with the Torrent irrigation tubing to provide irrigation via irrigation fluids such as sterile water supplied during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump (or electrosurgical unit). FDA UDI
- Model / Reference
- 00711784 FDA UDI
- Description
- The single use BioGuard air/water valve (4-piece) 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. The single use BioShield biopsy valve is used to cover the opening to the biopsy/suction channel of the gastrointestinal endoscope. The BioShield biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port thought the endoscopic procedure and provides access for irrigation. The single use Torrent irrigation scope connector is used in conjunction with the Torrent irrigation tubing to provide irrigation via irrigation fluids such as sterile water supplied during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump (or electrosurgical unit). FDA UDI
Identifiers
- Catalog Number
- 00711784 FDA UDI
- Primary DI / UDI-DI
- 00816765013007 FDA UDI
- FDA Product Code
- NWU FDA UDI
- GMDN Term
- Endoscope working-channel valve, 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
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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- US Endoscopy
Sources (1)
- FDA UDI e33ec973-91e8-4fc2-b16e-c57e2459a088 37 fields · synced May 30, 2026