DEVICE: STATVAC II Oxygen powered Aspirator (07540195053038)
Device Identifier (DI) Information
STATVAC II Oxygen powered Aspirator
01AS9502
In Commercial Distribution
01AS9502
O-Two Medical Technologies Inc
01AS9502
In Commercial Distribution
01AS9502
O-Two Medical Technologies Inc
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.
Device Characteristics
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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47367 | 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
[?]Product Code | Product Code Name |
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BTA | Pump, Portable, Aspiration (Manual Or Powered) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Storage Environment Temperature: between -40 and 60 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 12 Fluid Ounce |
Device Record Status
8aafe31f-57a2-423e-9e4e-5131df6f3fdc
August 23, 2018
3
September 23, 2016
August 23, 2018
3
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-387-3405
cs@otwo.com
cs@otwo.com