Clarus Dual HDMI Enclosure CD-HDMI

GUDID 00810004820807

The Clarus Dual HDMI Enclosure is a device used with a with a Clarus Digital Inspection Scope and is intended for the visual examination of the lumen of an instrument (typically an endoscope) to identify any dirt/debris within the lumen so that it can be removed prior to disinfection/sterilization; it is not intended for patient examination. The Clarus Dual HDMI Enclosure provides a white light source and facilitates the image from the camera sensor to a monitor. This is a reusable device.

CLARUS MEDICAL, LLC

Instrument inspection scope

• Primary Device ID: 00810004820807
• NIH Device Record Key: 21787031-41e2-4ee5-a833-df28cc0fbb6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clarus Dual HDMI Enclosure
• Version Model Number: CD-HDMI
• Catalog Number: CD-HDMI
• Company DUNS: 010316284
• Company Name: CLARUS MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810004820807 [Direct Marking]
GS1	10810004820804 [Primary]

FDA Product Code

• MNL: Accessories, Cleaning Brushes, For Endoscope

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-29
• Device Publish Date: 2022-07-21

Devices Manufactured by CLARUS MEDICAL, LLC

• 10810004821030 - Clarus Digital Inspection Scope, 1mm x 110cm, High Definition: 2024-02-28 Clarus Digital Inspection Scope, 1mm x 110cm, High Definition
• 00810004820012 - Clarus Digital ChannelScope Endoscope, 13.0cm: 2024-02-27 Clarus Digital ChannelScope Endoscope, 13.0cm
• 00810004820357 - Clarus Digital NeuroPEN Endoscope, 15.5cm: 2024-02-27 Clarus Digital NeuroPEN Endoscope, 15.5cm
• 00810004820395 - Clarus Digital ChannelScope Endoscope, 11.0cm: 2024-02-27 Clarus Digital ChannelScope Endoscope, 11.0cm
• 00810004820494 - Clarus Digital NeuroPEN Endoscope, 19.0cm: 2024-02-27 Clarus Digital NeuroPEN Endoscope, 19.0cm
• 00810004821026 - Clarus Digital ClarusScope Endoscope: 2024-02-27 Clarus Digital ClarusScope Endoscope
• 00810004821019 - Clarus Digital Control Module: 2024-02-27 Clarus Digital Control Module
• 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