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
Primary Device ID00608614333820
NIH Device Record Key6c274f91-a6e2-4eeb-adfe-93321bbcd1db
Commercial Distribution StatusIn Commercial Distribution
Brand NameIRRIS
Version Model Number045-04
Company DUNS532279330
Company NameA.R GUIDE IN MEDICAL LTD
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100608614333820 [Primary]
GS100693493006941 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTRTube, Tracheal (W/Wo Connector)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-12
Device Publish Date2019-04-04

On-Brand Devices [IRRIS]

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

Trademark Results [IRRIS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IRRIS
IRRIS
76491136 2862167 Live/Registered
Gannett Fleming Inc.
2003-02-19
IRRIS
IRRIS
73485762 1363027 Dead/Cancelled
L.N.K. CORPORATION
1984-06-18
IRRIS
IRRIS
73485753 1363026 Dead/Cancelled
L.N.K. CORPORATION
1984-06-18
IRRIS
IRRIS
73413177 not registered Dead/Abandoned
L. N. K. CORPORATION
1983-02-11
IRRIS
IRRIS
73413176 not registered Dead/Abandoned
L. N. K. CORPORATION
1983-02-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.