OES BRONCHOFIBERSCOPE

GUDID 04953170051142

BF-N20 2.2MM DIA W/O CH 55CM LENGTH

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible fibreoptic bronchoscope

• Primary Device ID: 04953170051142
• NIH Device Record Key: 216e1c8d-a805-4ee9-9ff7-fce25a6f2529
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OES BRONCHOFIBERSCOPE
• Version Model Number: OLYMPUS BF TYPE N20
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170051142 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K910423

FDA Product Code

• EOQ: BRONCHOSCOPE (FLEXIBLE OR RIGID)

Sterilization

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

[04953170051142]

Ethylene Oxide;High-level Disinfectant

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 [OES BRONCHOFIBERSCOPE]

• 04953170339394: OLYMPUS BF TYPE MP60
• 04953170339264: BF-1T60 6.0MM DIA 3.0MM CH 60CM LENGTH
• 04953170339240: BF-XP60 2.8MM DIA 1.2MM CH 60CM LENGTH
• 04953170339219: BF-3C40 3.6MM DIA 1.2MM CH 55CM LENGTH
• 04953170339196: BF-P60 5.0MM DIA 2.2MM CH 60CM LENGTH
• 04953170308277: OLYMPUS BF TYPE MP60
• 04953170308130: OLYMPUS BF TYPE 3C40
• 04953170051142: BF-N20 2.2MM DIA W/O CH 55CM LENGTH