REMOVABLE PATIENT CONTROL – 2 FUNCTIONS

Basic Information

• Brand Name: REMOVABLE PATIENT CONTROL – 2 FUNCTIONS
• Primary DI: 00670482000852
• Version / Model: FA64509-TRI
• Catalog Number: FA64509-TRI
• Company Name: Umano Medical Inc
• Labeler DUNS: 249675476
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-17
• Public Version: 1
• Public Version Date: 2024-09-25
• Public Version Status: New
• Public Device Record Key: cfd4d549-5b76-4887-ab1d-89939520b36b

Device Description

A hand-operated electronic device that has a functional connection to an electrically powered medical bed to control its operation

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: No
• Has Lot/Batch Number: Yes
• 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
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	880.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37991	Bed remote control	A hand-operated electronic device that has a functional connection to an electrically-powered medical bed to control its functions, typically the articulations and/or the raising/lowering of the bed. It may be connected to the bed via an electrical cable or operate cordless (wireless). It is typically operated by the occupant but may be utilized by the nursing/attending staff. Some types may integrate other functions for patient use (e.g., communication with the staff, radio/television operation).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10670482000859	GS1		1	In Commercial Distribution
Primary	00670482000852	GS1