Capital equipment to support the Leaf sensor patient montitoring system


Product Overview

Capital equipment to support the Leaf sensor patient montitoring system
LEAF™ - 66803065


Device Description

An electronic component of an ambulatory patient monitoring/recording system (e.g., ocular volume ambulatory recording system) designed to connect a patient-worn antenna to an ambulatory monitor/recorder for receiving and transmitting data between an implantable or nonimplantable sensor (used in close proximity to the antenna) and the monitor/recorder; it may also be intended to allow wireless power transfer from the parent device to the sensor via the antenna. It is in the form of an electronic circuitry housing with a cable and is powered by the monitor/recorder (battery-powered). This is a reusable device.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: KMI

Device Name: Monitor, Bed Patient

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 880.2400

Third Party Flag: N

Medical Specialty: HO


Device Identifiers

Device Id: 05000223499877

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


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