AccessGUDID - DEVICE: BioShield (00724995183516)

GUDID

Device Identifier (DI) Information

Brand Name: BioShield
Version or Model: 00711127
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00711127
Company Name: US Endoscopy

Primary DI Number: 00724995183516
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 627879687 *Terms of Use
Previous DI: 00816765011065

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62145	Endoscope working-channel valve, single-use	A device in the form of a small attachment intended to be fitted to the working channel (including biopsy port) of an endoscope to enable access for, and/or exchange of, an endoscopic device while minimizing leakage of liquids and gasses during an endoscopic procedure. Also referred to as a seal, it may be Luer formatted and include features to allow for simultaneous irrigation/biopsy or suction via the working channel. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ODD	Endoscopic retrograde cholangiopancreatography (ERCP) cannula
OCX	endoscopic irrigation/suction system
ODC	Endoscope channel accessory

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070420	000
K210342	000
K232951	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 60eb4829-d0aa-4104-a50a-a8ae68b35e06
Public Version Date: July 25, 2024
Public Version Number: 6
DI Record Publish Date: March 19, 2020