AccessGUDID - DEVICE: DEFENDO Valve and Connector Kit (00724995246792)

GUDID

Device Identifier (DI) Information

Brand Name: DEFENDO Valve and Connector Kit
Version or Model: 100315
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 100315
Company Name: MEDIVATORS INC.

Primary DI Number: 00724995246792
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 068199363 *Terms of Use
Previous DI: 00677964055911

Device Description: 4-piece kit, Single-Use Air Water, Suction and Biopsy Valves and Endogator Connector - Pentax

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?
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
ODC	Endoscope channel accessory
FDF	Colonoscope and accessories, flexible/rigid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K090851	000
K102409	000
K102581	000
K232004	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6e72b86d-9fbc-422b-bc69-a85f8247d695
Public Version Date: April 14, 2026
Public Version Number: 1
DI Record Publish Date: April 06, 2026