BioShield

Basic Information

• Brand Name: BioShield
• Primary DI: 00816765011034
• Version / Model: 00711124
• Catalog Number: 00711124
• Company Name: US Endoscopy
• Labeler DUNS: 627879687
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 7
• Public Version Date: 2021-03-19
• Public Version Status: Update
• Public Device Record Key: 6062e3dd-9f4e-41f4-bb2c-5431d2c3b64e
• Distribution End Date: 2020-03-17

Device 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ODD	Endoscopic retrograde cholangiopancreatography (ERCP) cannula	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62145	Endoscopic biopsy valve, single-use	A device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. It is typically in the form of a small attachment with an elastomer seal; it may include features to allow for simultaneous irrigation/biopsy, or to allow suction via the biopsy port. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10816765011031	GS1	Box	200	Not in Commercial Distribution	2020-03-17
Primary	00816765011034	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius