AccessGUDID - DEVICE: BioShield (10724995183544)

GUDID

Device Identifier (DI) Information

Brand Name: BioShield
Version or Model: 00711131
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00711131
Company Name: US Endoscopy

Primary DI Number: 10724995183544
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 627879687 *Terms of Use
Previous DI: 10816765011093

Device Description: The BioShield irrigating adaptor is used for intraprocedural gastrointestinal endoscopic irrigation when attached to a luer-lock or slip-tip syringe through the BioShield biopsy valve.

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
Needle Gauge: 15 Gauge
Length: 1 Inch

Device Record Status

Public Device Record Key: afe09800-ae80-4687-9077-4963d5cf7141
Public Version Date: July 25, 2024
Public Version Number: 6
DI Record Publish Date: March 19, 2020