DripAssist

GUDID 00856220006007

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.

SHIFT LABS, INC.

Intravenous gravity infusion monitor

• Primary Device ID: 00856220006007
• NIH Device Record Key: 40211e90-48e6-40ba-8dbe-a46559339536
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DripAssist
• Version Model Number: HDAB
• Company DUNS: 043288929
• Company Name: SHIFT LABS, INC.
• 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: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 206.369.1216
• Email: support@shiftlabs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856220006007 [Primary]

FDA Product Code

• FLN: Monitor, Electric For Gravity Flow Infusion Systems

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-04-01