BioGuard 00711783

GUDID 10816765012991

The single use BioGuard air/water valve (3-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.

US Endoscopy

Endoscopic biopsy valve, single-use

• Primary Device ID: 10816765012991
• NIH Device Record Key: 025bfb1f-021a-47e4-bc17-39a4dcf61dcb
• Commercial Distribution Discontinuation: 2020-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BioGuard
• Version Model Number: 00711783
• Catalog Number: 00711783
• Company DUNS: 627879687
• Company Name: US Endoscopy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816765012994 [Primary]
GS1	10816765012991 [Package]; Contains: 00816765012994; Package: Box [50 Units]; Discontinued: 2020-03-31; Not in Commercial Distribution

FDA Product Code

• NWU: Endoscope introducer kit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-03-31
• Device Publish Date: 2017-02-22

On-Brand Devices [BioGuard]

• 10816765013004: The single use BioGuard air/water valve (4-piece) is used to control the air / water function of
• 10816765012991: The single use BioGuard air/water valve (3-piece) is used to control the air / water function of
• 10816765012779: The single use BioGuard air/water valve is used to control the air/water function of an endoscop
• 10724995180550: The single use BioGuard air/water valve (4-piece) is used to control the air / water function of
• 10724995180543: The single use BioGuard air/water valve (3-piece) is used to control the air / water function of
• 10724995180536: The single use BioGuard air/water valve is used to control the air/water function of an endoscop
• 10724995180598: The BioGuard air/water cleaning adapter - Olympus is as part of the precleaning process, to help
• 10724995180581: The BioGuard valves (4-piece) and air/water cleaning adapter kit is used to control the suction
• 10724995180574: The BioGuard valves (3-piece) and air/water cleaning adapter kit is used to control the suction
• 10724995180567: The BioGuard valves and air/water cleaning adapter kit is used to control the suction function o