RFB LEVELERT II FLIUD LEVEL SENSOR
NA - 7211011F
Device Description
An electrically-powered device intended to be used to control and monitor the gravity infusion of intravenous (IV) fluids, providing an alarm (visible/audible) when pre-set limits are exceeded. It is available in two main configurations: 1) a device with an electronic flow sensor (drop counter) that monitors/measures the amount of fluid that passes through the infusion line; or 2) a device that measures the weight of the fluid container and may assist in bolus administration. The predetermined values may be selected by the user, and the device may display flow rate, total volume, and may record data. Some types can be used during arthroscopic procedures.
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: FLN
Device Name: Monitor, Electric For Gravity Flow Infusion Systems
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
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: 880.2420
Third Party Flag: Y
Medical Specialty: HO
Device Identifiers
Device Id: 00885556704127
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
