DEVICE: ClearLine MD (00863193000338)

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Device Identifier (DI) Information

ClearLine MD
Part#:2126

ANESTHESIA SAFETY PRODUCTS, LLC
00863193000338
GS1
1
ClearLine IV, (the new product name of AirPurge System - Control Unit), is intended for detection and automatic removal of air in intravenous lines during administration of intravenous solutions, blood and blood products. It is indicated for use in the Operating Room and post anesthesia care areas. The ClearLine IV is placed distal to I.V. bags using gravity feed or pressure, and may be used with or without fluid warmer.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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

GMDN Preferred Term Name GMDN Definition
Haemodialysis system air/foam detector A mains electricity (AC-powered) device designed to identify air bubbles and/or foam in blood returned to the body [usually through an arteriovenous fistula (AVF)] by the extracorporeal blood circuit of a haemodialysis system. It may detect the air bubbles/foam using either ultrasonic sensors (i.e., detecting changes in acoustic density), or less frequently using photoelectric sensors (e.g., a photocell). If bubbles/foam are detected, the device usually triggers alarms and activates automated mechanisms to stop the infusion.
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FDA Product Code

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Product Code Product Code Name
OKL Intravascular Administration Set, Automated Air Removal System
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 23, 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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
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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)

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Production Identifier(s) in UDI

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No CLOSE

Customer Contact

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No Customer Contact currently defined
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