DEVICE: O-Two Disposable Pressure manometer 0-20cmH2O (07540195037007)

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Device Identifier (DI) Information

O-Two Disposable Pressure manometer 0-20cmH2O
01CV8066
01CV8066
O-Two Medical Technologies Inc
07540195037007
GS1
1
O-Two Disposable Pressure Manometer is intended for use where monitoring airway pressure is desired. This device provides a visual indication of air way pressure to be used on O_Two Single-use "open Circuit" CPAP System.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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No
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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
Airway pressure monitor, non-powered A mechanical device designed to provide a visual indication of a patient's airway pressure during ventilation. It is typically contained in a clear housing marked with a pressure scale [e.g., 5 to 60 cm H20 (hPa)], and has a spring-loaded indicator that, in resistance to the expiratory flow of air, registers the airway pressure. It connects to the manometer port of a variety of ventilation devices such as a resuscitation bag, hyperinflation bag, continuous positive airway pressure (CPAP) mask, or a CPAP circuit. It may be used in a healthcare setting (including ambulatory) or in the home. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
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Sterilization

No
No
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
September 23, 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
17540195037004 25 07540195037007 In Commercial Distribution Packaging box
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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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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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