DEVICE: STATVAC II Oxygen powered Aspirator (07540195053014)

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Device Identifier (DI) Information

STATVAC II Oxygen powered Aspirator
01AS9500
01AS9500
O-Two Medical Technologies Inc
07540195053014
GS1
1
The O-Two Statvac® II Aspirator is capable of effectively suctioning out excessive quantities of fluid/particles from a patient’s oro/naso pharynx. The lightweight aspirator is designed to be attached to any 50 psi DISS outlet. The ON/OFF shuttle provides for fast actuation of the aspirator in an emergency. Continuous suction is provided by simply depressing the “GREEN” shuttle control. The aspiration can be quickly and easily turned off by depressing the “RED” shuttle control button on the opposite side of the aspirator.
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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
Pneumatic emergency suction system A portable assembly of devices primarily intended to be used by emergency medical services (EMS) to aspirate fluids, secretions, or other foreign materials from a patient's airway by means of suction. It typically consists of a gas-powered mechanism driven by medical air or oxygen (O2) from a gas cylinder to create the suction (e.g., a venturi tube), tubing, a collection container, a vacuum gauge and control knob, and a microbial filter. The pump creates a vacuum in the suction tubing which is used for the removal of materials into the collection container. This system is typically used during patient transport or for emergency situations.
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FDA Product Code

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Product Code Product Code Name
BTA Pump, Portable, Aspiration (Manual Or Powered)
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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
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 60 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Total Volume: 8 Fluid Ounce
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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
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)

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Yes
07540195053007
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Production Identifier(s) in UDI

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Customer Contact

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1-800-387-3405
cs@otwo.com
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