Capital equipment to support the Leaf sensor patient montitoring system
LEAF™ - 66802062
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: 05000223499914
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
