AccessGUDID - DEVICE: CleanGuard (10653405986485)

GUDID

Device Identifier (DI) Information

Brand Name: CleanGuard
Version or Model: 200310
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 200310
Company Name: Conmed Corporation

Primary DI Number: 10653405986485
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: CleanGuard Disposable Endoscope Valves Set, Contains Air/Water Valve, Suction Valve, Biopsy Valve and Auxiliary Water Connector

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):	No
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?
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
OCX	endoscopic irrigation/suction system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182998	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
Special Storage Condition, Specify: KEEP AWAY FROM SUNLIGHT

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8cda8cf9-22ff-45ac-bef2-c71f019ed353
Public Version Date: April 23, 2020
Public Version Number: 1
DI Record Publish Date: April 15, 2020