40657 Air Assist with Headrest

Basic Information

• Brand Name: 40657 Air Assist with Headrest
• Primary DI: 00787551039917
• Version / Model: 40657
• Catalog Number: 40657
• Company Name: XODUS MEDICAL, INC.
• Labeler DUNS: 868042664
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-12
• Public Version: 1
• Public Version Date: 2023-07-20
• Public Version Status: New
• Public Device Record Key: 294eee07-8c00-47a0-b84a-d746bf5377b1

Device Description

40657 Air Assist with Headrest

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• 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
FMR	DEVICE, TRANSFER, PATIENT, MANUAL	General Hospital	880.6785	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66835	Inflatable patient transfer sliding mattress, single-use	An inflatable device designed to: 1) support a recumbent patient on a bed or table; and 2) assist healthcare professionals in the physical movement and transfer of a patient (e.g., hospitalized, disabled, geriatric) from one place to another using sliding techniques; some types may additionally be designed to provide skin protection to prevent pressure sores and/or support a patient in a specific position (e.g., Trendelenburg). It includes patient straps, handles for transfer, air hose inlets, and requires a pump (not included) for inflation; it is not intended for patient lifting. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20787551039911	GS1	CASE	4	In Commercial Distribution
Primary	00787551039917	GS1

Customer Contacts

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