Iris AirShuttle™

Basic Information

• Brand Name: Iris AirShuttle™
• Primary DI: 10841962118733
• Version / Model: XT-5100-60
• Catalog Number: XT-5100-60
• Company Name: Qfix
• Labeler DUNS: 808875397
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-10
• Public Version: 2
• Public Version Date: 2023-12-11
• Public Version Status: Update
• Public Device Record Key: d5bdfb62-0b9b-4226-a4bc-f5b3bc93ad4a

Device Description

Iris AirShuttle™

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JAK	System, x-ray, tomography, computed	Radiology	892.1750	2
IYE	Accelerator, linear, medical	Radiology	892.5050	2
KPS	System, tomography, computed, emission	Radiology	892.1200	2
JAI	Couch, radiation therapy, powered	Radiology	892.5770	2
LNH	System, nuclear magnetic resonance imaging	Radiology	892.1000	2
FRZ	DEVICE, PATIENT TRANSFER, POWERED	General Hospital	880.6775	2
OUO	Tomographic imager combining emission computed tomography with nuclear magnetic resonance	Radiology	892.1200	2
LHN	System, radiation therapy, charged-particle, medical	Radiology	892.5050	2
IZI	System, X-Ray, Angiographic	Radiology	892.1600	2
OWB	Interventional Fluoroscopic X-Ray System	Radiology	892.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40536	Patient lifting system stretcher	A lifting device used together with a patient lifting system to provide a support for an incapacitated patient or a person with a disability that is being lifted in a lying (horizontal) position for transfer and (re)positioning. It is designed as an elongated framework with a solid or soft surface upon which the person to be lifted is placed and contained during the lifting process.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841962118733	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K230312	000

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 0 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal