EVIS EXERA BRONCHOVIDEOSCOPE

GUDID 04953170063039

OLYMPUS MEDICAL SYSTEMS CORP.

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• Primary Device ID: 04953170063039
• NIH Device Record Key: d948f9ff-2aaf-4836-ab39-03f6ce54ed4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVIS EXERA BRONCHOVIDEOSCOPE
• Version Model Number: OLYMPUS BF TYPE 3C160
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Device Count: 1
• DM Exempt: true
• 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
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170063039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023984

FDA Product Code

• EOQ: BRONCHOSCOPE (FLEXIBLE OR RIGID)

Sterilization

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

[04953170063039]

High-level Disinfectant;Ethylene Oxide

[04953170063039]

High-level Disinfectant;Ethylene Oxide

[04953170063039]

High-level Disinfectant;Ethylene Oxide

[04953170063039]

High-level Disinfectant;Ethylene Oxide

[04953170063039]

High-level Disinfectant;Ethylene Oxide

[04953170063039]

High-level Disinfectant;Ethylene Oxide

[04953170063039]

High-level Disinfectant;Ethylene Oxide

[04953170063039]

High-level Disinfectant;Ethylene Oxide

[04953170063039]

High-level Disinfectant;Ethylene Oxide

[04953170063039]

High-level Disinfectant;Ethylene Oxide

[04953170063039]

High-level Disinfectant;Ethylene Oxide

[04953170063039]

High-level Disinfectant;Ethylene Oxide

[04953170063039]

High-level Disinfectant;Ethylene Oxide

[04953170063039]

High-level Disinfectant;Ethylene Oxide

[04953170063039]

High-level Disinfectant;Ethylene Oxide

[04953170063039]

High-level Disinfectant;Ethylene Oxide

[04953170063039]

High-level Disinfectant;Ethylene Oxide

[04953170063039]

High-level Disinfectant;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-08
• Device Publish Date: 2016-09-21

On-Brand Devices [EVIS EXERA BRONCHOVIDEOSCOPE]

• 04953170340147: BF-XT160 VIDEOSCOPE 6.2MM DIA 3.2MM CH
• 04953170340031: BF-3C160 VIDEOSCOPE 3.8MM DIA 1.2MM CH
• 04953170063039: OLYMPUS BF TYPE 3C160