Zephyr Patient Positioning and Transfer System

Basic Information

• Brand Name: Zephyr Patient Positioning and Transfer System
• Primary DI: B237ZXLABP100
• Version / Model: ZXL-APB-10
• Company Name: Diacor, Inc.
• Labeler DUNS: 605813559
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-22
• Public Version: 2
• Public Version Date: 2023-06-14
• Public Version Status: Update
• Public Device Record Key: 45b9a917-eb12-46f5-a2e2-133f77b7a2bf

Device Description

Zephyr HP Accessory - Baseplate for S-Style thermoplastic masks

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: No
• 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
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	892.1000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40902	Radiological whole-body positioner	A device comprised of fixed or adjustable position elements designed to ensure adequate positioning and/or immobilization of a patient's whole body during diagnostic imaging, image guided surgical or interventional procedures, and/or radiation therapy procedures; it may in addition be used to position a patient’s body part (however it is not dedicated to a specific part of the body). It is in the form of a frame, board, cushion, or preformed pad and may be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.	No	Active
37160	Patient transfer system, powered	A mains electricity (AC-powered) assembly of devices used to transfer a supine patient, typically from his/her bed or transport stretcher to an operating table or vice versa. It is usually installed in large operating room (OR) complexes and serves as a sluice providing demarkation between the OR staff and the ward staff/porters and related devices. It may be designed as a motorized belt that is wider than the length of the patient and that rotates around a moveable pick-up plate which feeds in under the patient, drawing him/her onto the belt and depositing him/her onto an adjacent surface. It is typically fully automated, requiring no human intervention other than to operate the controls.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B237ZXLABP100	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K121929	000