AccessGUDID - DEVICE: BioGuard (00816765012772)

GUDID

Device Identifier (DI) Information

Brand Name: BioGuard
Version or Model: 00711780
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00711780
Company Name: US Endoscopy

Primary DI Number: 00816765012772
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 627879687 *Terms of Use

Device Description: The single use BioGuard air/water valve 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.

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:	Yes
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?
60760	Endoscope channel support kit	A collection of sterile devices intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes an endoscopic suction valve, an endoscopic air/water valve, and an endoscopic biopsy valve. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FDF	Colonoscope and accessories, flexible/rigid
ODC	Endoscope channel accessory

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192059	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c38745cf-a550-4c5e-8b3f-cfbb036d3497
Public Version Date: March 31, 2020
Public Version Number: 4
DI Record Publish Date: September 17, 2016