IRRIS (Infra-Red-Red Intubation System)
A.R Guide In Medical Ltd.
A.R GUIDE IN MEDICAL LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015283806 | 3015283806 | A.R GUIDE IN MEDICAL LTD. | 1 | N | 2020-04-25 | 13 Wadi El Haj Nazareth Ha Zafon IL 16000 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 228178 | 1109455534 | K171411 | IRRIS (Infra-Red-Red Intubation System) | BTR | 2018-01-12 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| BTR | 1 | 2018-01-12 |
PMN#
GUDID#
IRRIS - 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).
2019-04-04
IRRIS - 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)
2019-04-04