ENDOSCOPE REPROCESSOR

GUDID 04953170404047

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscope washer/disinfector

• Primary Device ID: 04953170404047
• NIH Device Record Key: f84ec93a-a18c-46fd-8aa3-9b7bf6edf10d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSCOPE REPROCESSOR
• Version Model Number: OER-Elite
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)401-1086
• Email: xx@xx.xx
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Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170404047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190969
• 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: 2020-09-14
• Device Publish Date: 2020-09-06

On-Brand Devices [ENDOSCOPE REPROCESSOR]

• 04953170258589: OER-Pro
• 04953170404047: OER-Elite
• 04953170331619: OER-MINI