Identity
- Trade Name
- BioGuard FDA UDI
- Generic Name
- Endoscopic insufflation tubing set, single-use FDA UDI
- Device Name
- The single use BioGuard air water valve, (4-piece kit) includes BioShield biopsy valve and Torrent irrigation scope connector is used to control the air water function of an endoscope during GI endoscopic procedures and support infection prevention practices, providing an alternative to manual cleaning and reprocessing. FDA UDI
- Model / Reference
- 00711784 FDA UDI
- Description
- The single use BioGuard air water valve, (4-piece kit) includes BioShield biopsy valve and Torrent irrigation scope connector is used to control the air water function of an endoscope during GI endoscopic procedures and support infection prevention practices, providing an alternative to manual cleaning and reprocessing. FDA UDI
Identifiers
- Catalog Number
- 00711784 FDA UDI
- Primary DI / UDI-DI
- 00724995180553 FDA UDI
- FDA Product Code
- PRT FDA UDI
- GMDN Term
- Endoscopic insufflation tubing set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 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
Similar devices
Also classified as Endoscope working-channel valve, single-use.
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- Edge — Covidien LP · Class II
- 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 898a5c16-3634-4554-9f7b-70359864141e 36 fields · synced May 30, 2026