DEVICE: CAREvent PAR (07540195025349)

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Device Identifier (DI) Information

CAREvent PAR
01CV0100
01CV0100
O-Two Medical Technologies Inc
07540195025349
GS1
1
CAREvent PAR assists the rescuer in providing efficient and effective CPR by providing with audible and visual prompts for chest compression, ventilation timing and automatic ventilation. The visual prompts aid the rescuer in their CPR efforts by providing illuminated pictograms of the CPR process, timed with the audible voice prompts. These voice and visual prompts help to significantly reduce interruptions in chest compression. The audible and visual warnings of mask leakage or airway obstruction assist the rescuer in ensuring that adequate tidal volumes are delivered.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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
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
Weight: 1.2 Kilogram
Height: 3.1 Inch
Width: 9.6 Inch
Length: 9.8 Inch
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Device Status

In Commercial Distribution
February 03, 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
07540195025332
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Production Identifier(s) in UDI

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No CLOSE

Customer Contact

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