DEVICE: DripAssist (00856220006007)

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Device Identifier (DI) Information

DripAssist
HDAB

SHIFT LABS, INC.
00856220006007
GS1
1
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.
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Device Characteristics

MR Unsafe
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Infusion controller, battery-powered A battery-powered device 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.
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FDA Product Code

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Product Code Product Code Name
FLN Monitor, Electric For Gravity Flow Infusion Systems
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
April 01, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+1 206.369.1216
support@shiftlabs.com
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