TRACHEAL INTUBATION FIBERSCOPE - OLYMPUS LF-P
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- High-level Disinfectant
- Ethylene Oxide
Product Codes
Code: EOQ
Device Name: Bronchoscope (Flexible Or Rigid)
Device Class: 2
Physical State: N/A
Definition: A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Submission Type ID: 1
Review Panel: EN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 874.4680
Third Party Flag: N
Medical Specialty: EN
Device IdentifiersDevice Id: 04953170452932
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A