Clarus TURBO LED Light Source

Basic Information

• Brand Name: Clarus TURBO LED Light Source
• Primary DI: B06751972010
• Version / Model: 5197-201
• Catalog Number: 5197-201
• Company Name: CLARUS MEDICAL, LLC
• Labeler DUNS: 010316284
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 37c3af32-1232-48a2-a7a7-eeed8f89c006

Device Description

Clarus TURBO LED Light Source

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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: High-level Disinfectant

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FTI	Lamp, Endoscope, Incandescent	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38659	Intubation light source	A device designed as a handle containing a light source used to provide cold light illumination for a patient's airways during access, intubation, and airway management. It is a pistol-grip-like device that contains the batteries that provide energy for the airway-illuminating lighting for the attached fibreoptic stylet and an illumination source (e.g., a halogen light bulb). This device is used together with other devices, e.g., stylets, oxygen (O2) connectors, a camera adaptor, typically to manage and document difficult airway intubations. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B06751972010	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K971455	000

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 60 – 90 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 100 Percent (%) Relative Humidity