Lumen AirShuttle

Basic Information

• Brand Name: Lumen AirShuttle
• Primary DI: 00841962120388
• Version / Model: XT-5100-80
• Catalog Number: XT-5100-80
• Company Name: Qfix
• Labeler DUNS: 808875397
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-02
• Public Version: 1
• Public Version Date: 2025-12-10
• Public Version Status: New
• Public Device Record Key: 2df2b709-b1a8-4153-a581-6f19060a8e6b

Device Description

Lumen 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 Safe
• 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
FRZ	Device, Patient Transfer, Powered	General Hospital	880.6775	2
IYE	Accelerator, Linear, Medical	Radiology	892.5050	2
IZI	System, X-Ray, Angiographic	Radiology	892.1600	2
JAI	Couch, Radiation Therapy, Powered	Radiology	892.5770	2
JAK	System, X-Ray, Tomography, Computed	Radiology	892.1750	2
KPS	System, Tomography, Computed, Emission	Radiology	892.1200	2
LHN	System, Radiation Therapy, Charged-Particle, Medical	Radiology	892.5050	2
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	892.1000	2
OUO	Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance	Radiology	892.1200	2
OWB	Interventional Fluoroscopic X-Ray System	Radiology	892.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37162	Patient transfer sliding board	A manual device used by healthcare professionals to assist in the physical movement and transfer of a person/patient (e.g., a hospitalized, a person with a disability, or a geriatric) from one position to another. The device typically has no lifting capabilities and utilizes sliding techniques to move the person. It is typically designed to transfer a person sideways from, e.g., a bed to a chair, or a bed to an operating table, or an operating table to a bed. It may be constructed as a solid sliding board with a low-friction surface, or a roller board (roller system in a framework).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841962120388	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K230312	000