WATER FILTER N6178801

GUDID 04953170438295

OLYMPUS MEDICAL SYSTEMS CORP.

Microbial water purification filter, non-sterilizable

• Primary Device ID: 04953170438295
• NIH Device Record Key: 51cb2705-3066-4fd9-b21d-91229d65133f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WATER FILTER
• Version Model Number: MAJ-824
• Catalog Number: N6178801
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)401-1086
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Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170438295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201920

FDA Product Code

• FEB: Accessories, Cleaning, For Endoscope

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-01
• Device Publish Date: 2023-04-22

On-Brand Devices [WATER FILTER]

• 04953170069482: MAJ-824
• 04953170401473: MAJ-2318
• 04953170438295: MAJ-824