DEFENDO

Basic Information

• Brand Name: DEFENDO
• Primary DI: 00724995229641
• Version / Model: 4008055
• Catalog Number: 4008055
• Company Name: MEDIVATORS INC.
• Labeler DUNS: 068199363
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-25
• Public Version: 2
• Public Version Date: 2024-07-16
• Public Version Status: Update
• Public Device Record Key: e2297f10-c3d1-42f5-9543-05e076f17adc

Device Description

Defendo Cleaning Adapter Non-Sterile

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ODC	Endoscope channel accessory	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65552	Endoscope flushing adaptor, single-use	A small attachment designed to be fitted to an endoscope port for flushing of the endoscope’s lumen(s) during post-procedural washing, disinfection and/or sterilization. It is in the form of a plug that may include a button/switch for control of fluid (e.g., sterilant, disinfectant) and/or air through the lumen; it does not include tubing (i.e., not a tubing set). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10724995229648	GS1	Box	50	In Commercial Distribution
Primary	00724995229641	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K240352	000