AccessGUDID - DEVICE: DEFENDO Air/Water and Suction Valves (00724995246730)

GUDID

Device Identifier (DI) Information

Brand Name: DEFENDO Air/Water and Suction Valves
Version or Model: 100306
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 100306
Company Name: MEDIVATORS INC.

Primary DI Number: 00724995246730
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 068199363 *Terms of Use
Previous DI: 00677964060274

Device Description: DEFENDO Air-Water and Suction Valves for OLYMPUS GI Endoscopes

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":	No
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?
60759	Endoscope suction valve, single-use	A device intended to be fitted to an endoscope suction channel to enable the operator to control suction whist preventing inflow of air. It is in the form of an attachable valve that controls (opens/closes) the suction channel. This is a single-use device.	Active	false
60758	Endoscope air/water valve, single-use	A device intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases [i.e., air, carbon dioxide (CO2)] for insufflation, and/or water for irrigation, whilst preventing backflow. It is in the form of an attachable inflow valve with closed and open settings. This is a single-use device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 61d69d5a-3ca5-417f-9b73-06b8d16b032a
Public Version Date: April 14, 2026
Public Version Number: 1
DI Record Publish Date: April 06, 2026