UmanoLocation

Basic Information

• Brand Name: UmanoLocation
• Primary DI: 00670482000814
• Version / Model: 284-0000-TRI
• Catalog Number: 284-0000-TRI
• Company Name: Umano Medical Inc
• Labeler DUNS: 249675476
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-27
• Public Version: 1
• Public Version Date: 2024-09-04
• Public Version Status: New
• Public Device Record Key: 189dfed0-b880-4f1a-829b-bba1af56e076

Device Description

UmanoLocation is a powered module that mounts to hospital wall or ceiling a fixed location.

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: 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
63888	Medical equipment non-clinical data monitoring software	An application software program intended to extract, process, and store non-clinical processing data (e.g., log of equipment usage, equipment status) from medical equipment (e.g., sterilizers/disinfectors, refrigerators) to assist process management. It is not intended for control of equipment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10670482000811	GS1		1	In Commercial Distribution
Primary	00670482000814	GS1
Package	20670482000818	GS1		10	In Commercial Distribution