CUSTOMED

Basic Information

• Brand Name: CUSTOMED
• Primary DI: M20890029822
• Version / Model: 712057342982
• Catalog Number: 9002982
• Company Name: CUSTOMED INC
• Labeler DUNS: 627572217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: e4ce1e81-631f-4440-a327-781ceb97445f

Device Description

ADJUSTABLE BESIDE RAILS

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	880.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46365	Basic electric home bed	A mains electricity (AC-powered) motorized bed designed to be used in the home by a patient for rest/sleep, and that provides the occupant with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard and a remote control to operate the electrical motors. The device typically raises the torso and/or legs to various heights. It may also include a heatable mattress and physical therapy pulsators.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M20890029822	HIBCC
Unit of Use	M20890029820	HIBCC

Customer Contacts

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