LEAF

Basic Information

• Brand Name: LEAF
• Primary DI: 05000223503994
• Version / Model: 66807745
• Catalog Number: 66807745
• Company Name: SMITH & NEPHEW MEDICAL LIMITED
• Labeler DUNS: 216344051
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-01
• Public Version: 1
• Public Version Date: 2026-03-09
• Public Version Status: New
• Public Device Record Key: ec9baf3d-ab04-473d-a1b0-c31f9b9b3046

Device Description

LEAF Hospital EMR System Integration Software Components

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• 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
KMI	MONITOR, BED PATIENT	General Hospital	880.2400	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65832	Wireless patient monitor/sensor reporting software, professional-only	A software program intended to be installed on an off-the-shelf, computerized device (e.g., desktop computer, tablet) and used by a healthcare professional in a clinical/care setting to receive data from a noninvasive, patient-worn, wireless monitor/sensor. It is not dedicated to bedside monitoring.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05000223503994	GS1

Customer Contacts

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