WATER CONTAINER

Basic Information

• Brand Name: WATER CONTAINER
• Primary DI: 04953170465949
• Version / Model: MAJ-901
• Catalog Number: N4451940
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-25
• Public Version: 1
• Public Version Date: 2024-12-03
• Public Version Status: New
• Public Device Record Key: 9502cbb2-66ff-4ea3-8e73-32919474cd5c

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: High-level Disinfectant, Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61156	Endoscopic irrigation/distension bottle	A device intended to be used during endoscopy procedures to provide a receptacle for irrigation water and a conduit for air/carbon dioxide (CO2) used for insufflation. It is typically in the form of an empty plastic bottle with a connector intended to attach to the proximal end of an endoscope and/or to a gas supply. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04953170465949	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K242357	000