LEAF™ 66803060

GUDID 05000223497446

A lightweight sensor that attaches to the patient’s chest, monitoring whether they are sitting, standing or lying down –on their left side, right side or back.

SMITH & NEPHEW MEDICAL LIMITED

Wearable multiple physiological parameter recorder

• Primary Device ID: 05000223497446
• NIH Device Record Key: 4a3b0ccb-a534-40a3-8091-0fbc21c067f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEAF™
• Version Model Number: 66803060
• Catalog Number: 66803060
• Company DUNS: 216344051
• Company Name: SMITH & NEPHEW MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	05000223497439 [Primary]
GS1	05000223497446 [Package]; Contains: 05000223497439; Package: Carton [10 Units]; In Commercial Distribution
GS1	05000223497453 [Package]; Contains: 05000223497439; Package: Case [1 Units]; In Commercial Distribution

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

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• 05000223497446: A lightweight sensor that attaches to the patient’s chest, monitoring whether they are sitting