LEAF™ 66802062

GUDID 05000223499914

Capital equipment to support the Leaf sensor patient montitoring system

SMITH & NEPHEW MEDICAL LIMITED

Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable Ambulatory monitoring/recording system transceiver/cable

• Primary Device ID: 05000223499914
• NIH Device Record Key: 8ecc8b23-0d87-4216-a7fb-6ede0e9d508c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEAF™
• Version Model Number: 66802062
• Catalog Number: 66802062
• Company DUNS: 216344051
• Company Name: SMITH & NEPHEW MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05000223499914 [Primary]

FDA Product Code

• KMI: Monitor, Bed Patient

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-02
• Device Publish Date: 2022-02-22

On-Brand Devices [LEAF™]

• 05000223499914: Capital equipment to support the Leaf sensor patient montitoring system
• 05000223499907: Capital equipment to support the Leaf sensor patient montitoring system
• 05000223499891: Capital equipment to support the Leaf sensor patient montitoring system
• 05000223499884: Capital equipment to support the Leaf sensor patient montitoring system
• 05000223499877: Capital equipment to support the Leaf sensor patient montitoring system
• 05000223497446: A lightweight sensor that attaches to the patient’s chest, monitoring whether they are sitting