DEVICE: Oxygen Demand Valve (07540195020122)

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Device Identifier (DI) Information

Oxygen Demand Valve
01DV3000
01DV3000
O-Two Medical Technologies Inc
07540195020122
GS1
1
The Oxygen Demand Valve provides 100% oxygen to patients suffering from respiratory distress at the flow rate demanded by the patient.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
Demand valve A non-sterile device that is used to regulate the therapeutic gas flow to a patient in response to the patient's breathing effort. It is used, e.g., in ventilator breathing circuits, resuscitation devices and in on demand analgesia devices. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
BTM Ventilator, Emergency, Manual (Resuscitator)
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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
Weight: 0.20 Kilogram
Height: 3.1 Inch
Outer Diameter: 2.0 Inch
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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
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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No
Yes
07540195020115
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Production Identifier(s) in UDI

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Yes
No CLOSE

Customer Contact

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