EVIS EXERA II BRONCHOVIDEOSCOPE

GUDID 04953170308192

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video bronchoscope, reusable

• Primary Device ID: 04953170308192
• NIH Device Record Key: 90cd0cad-98fb-4787-8789-e7b829c05a1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVIS EXERA II BRONCHOVIDEOSCOPE
• Version Model Number: OLYPUS BF TYPE P180
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170308192 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061313

FDA Product Code

• EOB: NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Sterilization

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

[04953170308192]

Ethylene Oxide;High-level Disinfectant

[04953170308192]

Ethylene Oxide;High-level Disinfectant

[04953170308192]

Ethylene Oxide;High-level Disinfectant

[04953170308192]

Ethylene Oxide;High-level Disinfectant

[04953170308192]

Ethylene Oxide;High-level Disinfectant

[04953170308192]

Ethylene Oxide;High-level Disinfectant

[04953170308192]

Ethylene Oxide;High-level Disinfectant

[04953170308192]

Ethylene Oxide;High-level Disinfectant

[04953170308192]

Ethylene Oxide;High-level Disinfectant

[04953170308192]

Ethylene Oxide;High-level Disinfectant

[04953170308192]

Ethylene Oxide;High-level Disinfectant

[04953170308192]

Ethylene Oxide;High-level Disinfectant

[04953170308192]

Ethylene Oxide;High-level Disinfectant

[04953170308192]

Ethylene Oxide;High-level Disinfectant

[04953170308192]

Ethylene Oxide;High-level Disinfectant

[04953170308192]

Ethylene Oxide;High-level Disinfectant

[04953170308192]

Ethylene Oxide;High-level Disinfectant

[04953170308192]

Ethylene Oxide;High-level Disinfectant

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 II BRONCHOVIDEOSCOPE]

• 04953170340086: BF-Q180-AC VIDEOSCOPE 5.3MM DIA 2.0MM CH
• 04953170339349: BF-1TQ180 VIDEOSCOPE 6.2MM DIA 2.8MM CH
• 04953170339325: BF-1T180 VIDEOSCOPE 6.0MM DIA 3.0MM CH
• 04953170339301: BF-Q180 VIDEOSCOPE 5.1MM DIA 2.0MM CH
• 04953170339288: BF-P180 VIDEOSCOPE 4.9MM DIA 2.0MM CH
• 04953170308222: OLYMPUS BF TYPE 1TQ180
• 04953170308215: OLYMPUS BF TYPE 1T180
• 04953170308208: OLYMPUS BF TYPE Q180
• 04953170308192: OLYPUS BF TYPE P180
• 04953170289002: OLYMPUS BF TYPE 1TQ180
• 04953170288975: OLYMPUS BF TYPE 1T180
• 04953170288937: OLYMPUS BF TYPE Q180