TRACHEAL INTUBATION FIBERSCOPE

Basic Information

• Brand Name: TRACHEAL INTUBATION FIBERSCOPE
• Primary DI: 04953170061998
• Version / Model: OLYMPUS LF-GP
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• Labeler DUNS: 711789789
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 5
• Public Version Date: 2023-01-16
• Public Version Status: Update
• Public Device Record Key: 15887494-3f30-4bb7-b577-14e3a14a9c23

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Ethylene Oxide", "High-level Disinfectant"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EOQ	BRONCHOSCOPE (FLEXIBLE OR RIGID)	Ear, Nose, Throat	874.4680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36706	Flexible fibreoptic intubation laryngoscope	An endoscope with a flexible inserted portion intended for the visual examination of the upper airway and to assist the entry and positioning of a special airway tube [a long thin version of an endotracheal (ET) tube] to secure an open airway in the case of difficult and non-difficult intubation procedures. The inserted portion is very long and thin to facilitate entry and the intubation procedure. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04953170061998	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]