DEVICE: CARevent CPAP (07540195036017)

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Device Identifier (DI) Information

CARevent CPAP
01CV0200-1
01CV0200
O-Two Medical Technologies Inc
07540195036017
GS1
1
The handheld CAREvent® CPAP provides CPAP delivery in a simple, compact device that can fit easily into existing oxygen kit. The ease-of-use design concept and unique single-use patient circuit with facemask, head harness and airway pressure gauge make application and operation of the O-Two CAREvent CPAP extremely simple for the rescuer and more comfortable and less distressing for the patient.
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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
Emergency CPAP set, nebulizing A portable collection of devices intended to be connected to a medical gas supply to assist noninvasive ventilation (i.e., without an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous respiration, typically in emergency situations (associated with e.g., acute pulmonary embolism, pulmonary oedema, near drowning) or after extubation. It includes an emergency CPAP device (a small plastic unit intended to establish a gas pressure proportional to gas flow rate), a face mask, a nebulizer, and may include additional components (e.g., manometer, flowmeter, tubing, mask strap). This is a reusable device once the consumable products have been replenished.
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FDA Product Code

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Product Code Product Code Name
BTL Ventilator, Emergency, Powered (Resuscitator)
BYE Attachment, Breathing, Positive End Expiratory Pressure
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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: 0.45 Kilogram
Height: 2.9 Inch
Width: 2.5 Inch
Length: 5.5 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
07540195036000
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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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