Clarus TURBO LED Light Source 5197-201

GUDID B06751972010

Clarus TURBO LED Light Source

CLARUS MEDICAL, LLC

Intubation light source

• Primary Device ID: B06751972010
• NIH Device Record Key: 37c3af32-1232-48a2-a7a7-eeed8f89c006
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clarus TURBO LED Light Source
• Version Model Number: 5197-201
• Catalog Number: 5197-201
• Company DUNS: 010316284
• Company Name: CLARUS MEDICAL, LLC
• 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: false
• 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: 763-525-8400
• Email: admin@clarus-medical.com
• Phone: 763-525-8400
• Email: admin@clarus-medical.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B06751972010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971455

FDA Product Code

• FTI: Lamp, Endoscope, Incandescent

Sterilization

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

[B06751972010]

High-level Disinfectant

[B06751972010]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

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• 00810004820005 - Clarus Digital Inspection Scope, 1.9mm OD: 2022-07-29 The Clarus Inspection Scope is a device with a flexible working length intended for the visual examination of the lumen of an in