DEVICE: Oxygen Sensor (04036616000390)

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Device Identifier (DI) Information

Oxygen Sensor
OOM103-1M
01-00-0090
EnviteC-Wismar GmbH
04036616000390
GS1
1
Oxygen Sensor OOM103-1M
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Device Characteristics

MR Unsafe
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Respiratory oxygen sensor A device designed to detect the presence and determine the concentration of oxygen (O2) by paramagnetic, electrochemical, or other technique. The device is typically used as a component of an oxygen monitor or a patient monitoring device/system that determines the percentage of O2 in medical gases used in an enclosed atmosphere (e.g., an anaesthesia or ventilator circuit, oxygen tent, oxygen therapy device/system tubing) inspired by a patient. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
CCL Analyzer, Gas, Oxygen, Gaseous-Phase
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Atmospheric Pressure: between 60 and 200 KiloPascal
Handling Environment Temperature: between 0 and 50 Degrees Celsius
Storage Environment Humidity: between 0 and 99 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 50 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Height: 30 Millimeter
Width: 150 Millimeter
Length: 247 Millimeter
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Device Status

In Commercial Distribution
September 22, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+493841360324
christian.walsleben@honeywell.com
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