DEVICE: CAREvent EMT (07540195025059)
Device Identifier (DI) Information
CAREvent EMT
01CV1100
In Commercial Distribution
01CV1100
O-Two Medical Technologies Inc
01CV1100
In Commercial Distribution
01CV1100
O-Two Medical Technologies Inc
The CAREvent EMT kit contains a CAREvent EMT resuscitator and a pressure regulator in moulded case.
The CAREvent EMT hand held automatic resuscitator is pneumatically powered, time/volume cycled ventilatlatory resuscitator. It provides trained individuals with a safe and effective means of providing artificial ventilation during respiratory and cardiac arrest. The CAREvent EMT delivers automatic ventilation with controlled flow rates, airway pressure, tidal volume and frequencies. Patients are protected from over inflation and potential barotraumas by an audible Pressure Relief System.
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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13366 | Pulmonary resuscitator, pneumatic, reusable |
A device designed to provide or assist ventilation in a patient who is apnoeic or exhibits inadequate respiration through automatic pneumatic-driven pressure cycle functions. It is connected to a source of compressed oxygen (O2) and, if not entrained, medical air via oxygen/air terminal units or gas cylinder(s). It typically includes gas supply tubing, a breathing circuit with, e.g., a gas control modulator, gas connector(s), safety valves, and a flex connector to connect to a face mask or endotracheal (ET) tube. It is used in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), and mass casualty incidents (MCI). This is a reusable device.
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FDA Product Code
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FDA Premarket Submission
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
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Storage Environment Temperature: between -40 and 60 Degrees Celsius |
Clinically Relevant Size
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Device Record Status
01a9346e-8b6c-42d7-b576-ca77a3de563f
March 29, 2018
2
October 26, 2015
March 29, 2018
2
October 26, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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Unit of Use DI
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Unit of Use DI Number:
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-387-3405
cs@otwo.com
cs@otwo.com