Identity
- Trade Name
- IRRIS FDA UDI
- Generic Name
- Intubation light source FDA UDI
- Device Name
- 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). FDA UDI
- Model / Reference
- 045-04 FDA UDI
- 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). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00608614333820 FDA UDI
- 510(k) Number
- K171411 FDA UDI
- FDA Product Code
- BTR FDA UDI
- GMDN Term
- Intubation light source FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5730 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intubation light source
Irris by A.R Guide IN Medical , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intubation light source.
- Medline — MEDLINE INDUSTRIES, INC. · Class I
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- BritePro Single-Use Fiber Optic Lightsource — FLEXICARE MEDICAL LIMITED · Class I
- IRRIS — A.R Guide IN Medical , Ltd. · Class II
Cleared under the same submission
K171411 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- A.R Guide IN Medical , Ltd.
Sources (1)
- FDA UDI 6c274f91-a6e2-4eeb-adfe-93321bbcd1db 34 fields · synced May 30, 2026