EVIS EXERA BRONCHOFIBERVIDEOSCOPE

GUDID 04953170340093

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video bronchoscope, reusable

• Primary Device ID: 04953170340093
• NIH Device Record Key: 7aa7deff-8c74-4bfc-9728-08429e1287d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVIS EXERA BRONCHOFIBERVIDEOSCOPE
• Version Model Number: OLYMPUS BF TYPE XP160F
• 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
• 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	04953170340093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033225

FDA Product Code

• EOQ: BRONCHOSCOPE (FLEXIBLE OR RIGID)

Sterilization

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

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

High-level Disinfectant;Ethylene Oxide

[04953170340093]

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 BRONCHOFIBERVIDEOSCOPE]

• 04953170340116: BF-XP160F VIDEOSCOPE 2.8MM DIA 1.2MM CH
• 04953170340093: OLYMPUS BF TYPE XP160F
• 04953170340048: OLYMPUS BF TYPE MP160F
• 04953170289064: OLYMPUS BF TYPE MP160F
• 04953170289033: OLYMPUS BF TYPE XP160F