DripAssist

Basic Information

• Brand Name: DripAssist
• Primary DI: 00856220006007
• Version / Model: HDAB
• Company Name: SHIFT LABS, INC.
• Labeler DUNS: 043288929
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-01
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 40211e90-48e6-40ba-8dbe-a46559339536

Device Description

The DripAssist device is intended to be used as a supplementary monitoring system for monitoring the flow rate of intravenous fluids. The DripAssist is a passive device. It does not control the flow rate of fluids passing through a drip chamber. The device operates by monitoring the drops through the drip chamber of a standard IV administration set. By tracking the intervals between drops, the device calculates the flow rate through the chamber and displays the flow rate on an LCD screen. The device operates by tracking drops using an infrared emitter and detector positioned on opposite sides of a well wherein the drip chamber is situated. There is an alarm functionality that can be activated once a desired flow rate, or “set point,” is reached. The alarm, when activated, will sound when the flow rate deviates from a fixed percentage from the “set point.” The device can be used with drip sets of 10, 15, 20, and 60 gtt/mL. The device is powered by one AA battery. The device can display the flow rate in drops per minute or mL per hour. The unit of measurement being displayed can be changed while the device operates. The device can also display the total volume that has dispensed through the drip chamber. The device is designed to be used with drip rates slow enough to be calculated by the human eye; a steady stream of fluid is outside the operating parameters.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FLN	Monitor, Electric For Gravity Flow Infusion Systems	General Hospital	880.2420	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46847	Intravenous gravity infusion monitor	An electronic device intended to monitor and display the volume and flow rate of intravenous (IV) fluids administration during gravity infusion, providing an alarm (visible/audible) when pre-set limits are exceeded. It is attached directly to the drip chamber of the infusion set and functions by means of a sensor (drop counter) designed to measure the amount of fluid passing through the infusion line and/or by measuring the weight of the fluid container. It includes a display screen, and may record data and be capable of wireless connectivity for data transfer.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856220006007	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]