IRRIS

Primary DI
00608614324521
Brand
IRRIS
Company
A.R GUIDE IN MEDICAL LTD
Model
025-04
Device description
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)
Published
2019-04-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BTRTube, Tracheal (W/Wo Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171411000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171411000IRRIS (Infra-Red-Red Intubation System)A.R Guide IN Medical , Ltd.2018-01-12BTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00608614324521PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00608614324521006086143245216086143245210608614324521

GMDN Terms#

Term, Definition table
TermDefinition
Intubation light sourceA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532279330
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00608614333820IRRIS045-042019-04-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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