DEVICE: SuctionShield (00861283000312)

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Device Identifier (DI) Information

SuctionShield
PSC5300

PATIENT SHIELD CONCEPTS, LLC
00861283000312
GS1
100
The holster device provides safe and convenient storage of the Yankauer Suction Tip between suctions of the individual patient. It is designed to avoid contamination of the individual patient's suction tip by preventing contact of the tip with any surface other than the patient's own disposable holster or cross contamination of other patients and healthcare personnel. The device is a disposable, plastic, wide mouthed receptacle, intended to be attached to the patient's bed rail.
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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
Tracheal suction catheter A flexible tube typically made of plastic designed for periodic aspiration of liquids and/or semi-solids from a patient's upper airway. The tube is usually 40 to 56 cm (16 to 22 inches) in length and of small enough diameter to fit through an endotracheal (ET) tube. It usually has a smooth and rounded distal-tip configuration, including end and side holes; most include a finger-controlled valve to regulate the suctioning pressure. The device is externally attached through a large-diameter extension tube to a vacuum system and collection jar; it is used to remove excessive internal secretions from the lungs, bronchi, trachea, and pharynx. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
JOL Catheter And Tip, Suction
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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
August 08, 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
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: 00086128000312 CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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