DEVICE: WaterPAP PRO (00862146000319)

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Device Identifier (DI) Information

WaterPAP PRO
WP-7800

AIRWAYS DEVELOPMENT COMPANY LLC
00862146000319
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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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
Mechanical expiratory valve, single-use A non-sterile mechanical device intended to be used in a respiratory or anaesthesia breathing circuit or system to maintain a degree of positive pressure in a patient's airway at the end of expiration. Typically constructed of plastic/metal it has a valve that is actuated by a spring to provide expiratory airway resistance, and an adjustable knob (usually not graduated) that is typically set between 0 and 20 cmH20 pressure, but may be fully closed when controlled/assisted ventilation is applied. It is normally used with anaesthesia breathing systems, pulmonary resuscitators, or ventilators and is commonly known as a pop-off valve, relief valve, or spill valve. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
BYE Attachment, Breathing, Positive End Expiratory Pressure
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Sterilization

No
No
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 26, 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
40862146000300 4 30862146000303 In Commercial Distribution Case
30862146000303 10 00862146000319 In Commercial Distribution Box
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
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No CLOSE

Customer Contact

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No Customer Contact currently defined
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