EVIS EXERA BRONCHOFIBERVIDEOSCOPE

GUDID 04953170340048

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible video bronchoscope, reusable Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope Flexible fibreoptic bronchoscope

• Primary Device ID: 04953170340048
• NIH Device Record Key: 60dfcfeb-71cf-40e2-8c99-febe503f805a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVIS EXERA BRONCHOFIBERVIDEOSCOPE
• Version Model Number: OLYMPUS BF TYPE MP160F
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170340048 [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

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

High-level Disinfectant;Ethylene Oxide

[04953170340048]

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