Identity
- Trade Name
- BioShield FDA UDI
- Generic Name
- Endoscope working-channel valve, single-use FDA UDI
- Device Name
- The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a gastrointestinal endoscope. It provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the gastrointestinal endoscopic procedure. FDA UDI
- Model / Reference
- 00711127 FDA UDI
- Description
- The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a gastrointestinal endoscope. It provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the gastrointestinal endoscopic procedure. FDA UDI
Identifiers
- Catalog Number
- 00711127 FDA UDI
- Primary DI / UDI-DI
- 00724995183516 FDA UDI
- FDA Product Code
- ODD FDA UDIOCX FDA UDIODC 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Category: Endoscope working-channel valve, single-use
BioShield by US Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope working-channel valve, single-use.
- Dragonfly Pancreaticobiliary Scope and Instrument Channel Caps — CenterPoint Systems LLC · Class II
- Disposable Biopsy Valve — Micro-tech Usa · Class II
- Edge — Covidien LP · Class II
- CONMED CLEARGUARD — Conmed Corporation · Class II
- Edge — Covidien LP · Class II
- Edge — Covidien LP · Class II
- Edge — Covidien LP · Class II
- SINGLE USE BIOPSY VALVE (Sterile) — Olympus Medical Systems Corporation · Class II
Cleared under the same submission
K070420 also covers:
K210342 also covers:
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 60eb4829-d0aa-4104-a50a-a8ae68b35e06 37 fields · synced Jun 8, 2026