IRRIS

GUDID 00608614333820

The IRRIS is designed for use as an aid in the placement of an endotracheal tube (ETT) during intubation procedures performed with video-assisted devices. The IRRIS is a non-invasive electronic illumination device. The device transmits light of a specific wavelength (near infra-red) to the underlying tissues. The light enables to illuminate the trachea of the patient, so it can be distinguished from other tissues while using video assisted devices (video-laryngoscopes).

A.R GUIDE IN MEDICAL LTD

Intubation light source Intubation light source

• Primary Device ID: 00608614333820
• NIH Device Record Key: 6c274f91-a6e2-4eeb-adfe-93321bbcd1db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRRIS
• Version Model Number: 045-04
• Company DUNS: 532279330
• Company Name: A.R GUIDE IN MEDICAL LTD
• Device Count: 10
• DM Exempt: false
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00608614333820 [Primary]
GS1	00693493006941 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171411

FDA Product Code

• BTR: Tube, Tracheal (W/Wo Connector)

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: 2019-04-12
• Device Publish Date: 2019-04-04

On-Brand Devices [IRRIS]

• 00608614333820: The IRRIS is designed for use as an aid in the placement of an endotracheal tube (ETT) during in
• 00608614324521: The IRRIS is designed for use as an aid in the placement of an endotracheal tube (ETT) during in