EVIS EXERA III BRONCHOVIDEOSCOPE

GUDID 04953170335174

BF-H190 EEIII HIGH DEF DIAGNOS IC BRONCH

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video bronchoscope, reusable

• Primary Device ID: 04953170335174
• NIH Device Record Key: b3307b90-e06e-4dd0-b817-f7fd79568566
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVIS EXERA III BRONCHOVIDEOSCOPE
• Version Model Number: OLYMPUS BF-H190
• 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
• 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	04953170335174 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121959

FDA Product Code

• EOQ: BRONCHOSCOPE (FLEXIBLE OR RIGID)

Sterilization

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

[04953170335174]

High-level Disinfectant;Ethylene Oxide

[04953170335174]

High-level Disinfectant;Ethylene Oxide

[04953170335174]

High-level Disinfectant;Ethylene Oxide

[04953170335174]

High-level Disinfectant;Ethylene Oxide

[04953170335174]

High-level Disinfectant;Ethylene Oxide

[04953170335174]

High-level Disinfectant;Ethylene Oxide

[04953170335174]

High-level Disinfectant;Ethylene Oxide

[04953170335174]

High-level Disinfectant;Ethylene Oxide

[04953170335174]

High-level Disinfectant;Ethylene Oxide

[04953170335174]

High-level Disinfectant;Ethylene Oxide

[04953170335174]

High-level Disinfectant;Ethylene Oxide

[04953170335174]

High-level Disinfectant;Ethylene Oxide

[04953170335174]

High-level Disinfectant;Ethylene Oxide

[04953170335174]

High-level Disinfectant;Ethylene Oxide

[04953170335174]

High-level Disinfectant;Ethylene Oxide

[04953170335174]

High-level Disinfectant;Ethylene Oxide

[04953170335174]

High-level Disinfectant;Ethylene Oxide

[04953170335174]

High-level Disinfectant;Ethylene Oxide

[04953170335174]

High-level Disinfectant;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [EVIS EXERA III BRONCHOVIDEOSCOPE]

• 04953170342134: BF-XP190 EVIS EXERA III ULTRA SLM BRNCH
• 04953170342110: BF-P190 EVIS EXERA III SLIM BRONCH 4.1MM
• 04953170335198: BF-Q190 EEIII Q-IMAGE DIAGNOST IC BRONCH
• 04953170335181: BF-1TH190 EEIII HD THERAPEUTIC BRONCH W
• 04953170335174: BF-H190 EEIII HIGH DEF DIAGNOS IC BRONCH
• 04953170434990: OLYMPUS BF-XP190
• 04953170434983: OLYMPUS BF-P190
• 04953170434792: OLYMPUS BF-Q190
• 04953170434778: OLYMPUS BF-1TH190
• 04953170434754: OLYMPUS BF-H190