BioShield 00711903

GUDID 10724995199255

The BioShield EUS biopsy valve-linear is used to cover the opening to the biopsy, suction channel of flexible gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure and provides access for irrigation.

US Endoscopy

Endoscopic biopsy valve, single-use

• Primary Device ID: 10724995199255
• NIH Device Record Key: cddcef30-e08f-4f87-b0c2-ed0d3bb58aed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioShield
• Version Model Number: 00711903
• Catalog Number: 00711903
• Company DUNS: 627879687
• Company Name: US Endoscopy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995199258 [Primary]
GS1	10724995199255 [Package]; Contains: 00724995199258; Package: Case [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202583

FDA Product Code

• ODD: Endoscopic retrograde cholangiopancreatography (ERCP) cannula

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-23
• Device Publish Date: 2021-09-15

On-Brand Devices [BioShield]

• 10816765011147: The BioShield irrigator is used with gastrointestinal endoscopes and allows for remote irrigatio
• 10816765011130: The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a
• 10816765011123: The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a
• 10816765011116: The BioShield irrigator extension tubing is used for attachment to an auxiliary water pump for h
• 10816765011109: The BioShield irrigator is used with gastrointestinal endoscopes and allows for remote irrigatio
• 10816765011079: The BioShield biopsy valve - sterile is used to cover the opening to the biopsy/suction channel
• 10816765011062: The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a
• 10816765011055: The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a
• 10816765011031: The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a
• 20816765013407: The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a
• 20816765013391: The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a
• 10816765011093: The BioShield irrigating adaptor is used for intraprocedural gastrointestinal endoscopic irrigat
• 00724995183547: The BioShield irrigating adaptor is used for intraprocedural gastrointestinal endoscopic irrigat
• 20724995183534: The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a
• 20724995183497: The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a
• 10724995183599: The BioShield irrigator is used with gastrointestinal endoscopes and allows for remote irrigatio
• 10724995183582: The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a
• 10724995183575: The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a
• 10724995183568: The BioShield irrigator extension tubing is used for attachment to an auxiliary water pump for h
• 10724995183551: The BioShield irrigator is used with gastrointestinal endoscopes and allows for remote irrigatio
• 10724995183520: The BioShield biopsy valve - sterile is used to cover the opening to the biopsy/suction channel
• 10724995183513: The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a
• 10724995183506: The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a
• 10724995183483: The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a
• 10724995199255: The BioShield EUS biopsy valve-linear is used to cover the opening to the biopsy, suction channe
• 10724995199248: The BioShield EUS biopsy valve-linear is used to cover the opening to the biopsy, suction channe