DEVICE: CAREvent ALS (07540195025110)

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Device Identifier (DI) Information

CAREvent ALS
01CV3100
01CV3100
O-Two Medical Technologies Inc
07540195025110
GS1
1
CAREvent ALS kit 01CV3100 contains a CAREvent ALS resuscitator and a pressure regulator. CAREvent ALS 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 ALS 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. In addition, CAREvent ALS allows the breathing patient to “Demand Breathe” on 100% oxygen at their own rate and volume.
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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
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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Product Code Product Code Name
BTL Ventilator, Emergency, Powered (Resuscitator)
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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 Temperature: between -40 and 60 Degrees Celsius
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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
October 26, 2015

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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
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Secondary DI

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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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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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