Iris AirShuttle™

FDA UDI

Class II (US FDA UDI)

by Qfix

Identity

Trade Name: Iris AirShuttle™ FDA UDI
Generic Name: Patient lifting system stretcher FDA UDI
Device Name: Iris AirShuttle™ FDA UDI
Model / Reference: XT-5100-60 FDA UDI
Description: Iris AirShuttle™ FDA UDI

Identifiers

Catalog Number: XT-5100-60 FDA UDI
Primary DI / UDI-DI: 10841962118733 FDA UDI
510(k) Number: K230312 FDA UDI
FDA Product Code: JAK FDA UDI
IYE FDA UDI
KPS FDA UDI
JAI FDA UDI
LNH FDA UDI
FRZ FDA UDI
OUO FDA UDI
LHN FDA UDI
IZI FDA UDI
OWB FDA UDI
GMDN Term: Patient lifting system stretcher FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1750 FDA UDI
892.5050 FDA UDI
892.1200 FDA UDI
892.5770 FDA UDI
892.1000 FDA UDI
880.6775 FDA UDI
892.1600 FDA UDI
892.1650 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Patient lifting system stretcher

Iris AirShuttle™ by Qfix — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient lifting system stretcher.

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Zephyr Patient Positioning and Transfer System — Diacor Inc. · Class I
Transfer board — Mobilex A/S · Class I
Powered Loading System (PLS) (Component) — LIFEPORT, LLC. · Class I
INSTALLATION, POWER LOADING SYSTEM, CESSNA 680 * PLS — LIFEPORT, LLC. · Class I
Zephyr Patient Positioning and Transfer System — Diacor Inc. · Class I

Cleared under the same submission

K230312 also covers:

Alpine Stirrups — Qfix
Alpine Stirrups — Qfix

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: Qfix

Sources (1)

FDA UDI d5bdfb62-0b9b-4226-a4bc-f5b3bc93ad4a 37 fields · synced May 30, 2026