DEVICE: STATVAC II Oxygen powered Aspirator (07540195053014)

Device Identifier (DI) Information

STATVAC II Oxygen powered Aspirator
01AS9500
In Commercial Distribution
01AS9500
O-Two Medical Technologies Inc
07540195053014
GS1

1
206449154 *Terms of Use
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
No
Yes
No
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
Emergency airway clearance suction system, pneumatic A portable assembly of devices, which includes a non-surgical invasive component, intended to aspirate unwanted materials (e.g., fluids, secretions) from the airway typically during patient transport or an emergency situation (e.g., placed on a crash cart), by means of suction generated from a compressed gas supply (the Venturi principle). It includes a pneumatic suction regulator which controls the degree of negative pressure for aspiration, a portable supply of compressed gas (e.g., cylinder of air or oxygen), collection containers, tubing, microbial/hydrophobic filters, and patient contact devices (e.g., handpiece/tip, mask).
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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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
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 Record Status

8b4b4248-3c95-43f7-8b75-240ac8e6323f
August 23, 2018
3
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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No
Yes
07540195053007
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Production Identifier(s) in UDI

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Yes
Yes
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No CLOSE

Customer Contact

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