Oxygen Sensor E01-00-0020

GUDID 04036616000369

Oxygen Sensor OOM102-1

EnviteC-Wismar GmbH

Respiratory oxygen sensor

• Primary Device ID: 04036616000369
• NIH Device Record Key: d8cdc13a-d8f0-444d-a19b-f9d3f0a5566f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oxygen Sensor
• Version Model Number: OOM102-1
• Catalog Number: E01-00-0020
• Company DUNS: 330943838
• Company Name: EnviteC-Wismar GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49384360324
• Email: Christian.Walsleben@honeywell.com
• Phone: +49384360324
• Email: Christian.Walsleben@honeywell.com
• Phone: +49384360324
• Email: Christian.Walsleben@honeywell.com
• Phone: +49384360324
• Email: Christian.Walsleben@honeywell.com
• Phone: +49384360324
• Email: Christian.Walsleben@honeywell.com
• Phone: +49384360324
• Email: Christian.Walsleben@honeywell.com
• Phone: +49384360324
• Email: Christian.Walsleben@honeywell.com
• Phone: +49384360324
• Email: Christian.Walsleben@honeywell.com
• Phone: +49384360324
• Email: Christian.Walsleben@honeywell.com
• Phone: +49384360324
• Email: Christian.Walsleben@honeywell.com
• Phone: +49384360324
• Email: Christian.Walsleben@honeywell.com
• Phone: +49384360324
• Email: Christian.Walsleben@honeywell.com
• Phone: +49384360324
• Email: Christian.Walsleben@honeywell.com
• Phone: +49384360324
• Email: Christian.Walsleben@honeywell.com
• Phone: +49384360324
• Email: Christian.Walsleben@honeywell.com
• Phone: +49384360324
• Email: Christian.Walsleben@honeywell.com
• Phone: +49384360324
• Email: Christian.Walsleben@honeywell.com
• Phone: +49384360324
• Email: Christian.Walsleben@honeywell.com

Device Dimensions

• Height: 30 Millimeter
• Length: 247 Millimeter
• Width: 150 Millimeter
• Height: 30 Millimeter
• Length: 247 Millimeter
• Width: 150 Millimeter
• Height: 30 Millimeter
• Length: 247 Millimeter
• Width: 150 Millimeter
• Height: 30 Millimeter
• Length: 247 Millimeter
• Width: 150 Millimeter
• Height: 30 Millimeter
• Length: 247 Millimeter
• Width: 150 Millimeter
• Height: 30 Millimeter
• Length: 247 Millimeter
• Width: 150 Millimeter
• Height: 30 Millimeter
• Length: 247 Millimeter
• Width: 150 Millimeter
• Height: 30 Millimeter
• Length: 247 Millimeter
• Width: 150 Millimeter
• Height: 30 Millimeter
• Length: 247 Millimeter
• Width: 150 Millimeter
• Height: 30 Millimeter
• Length: 247 Millimeter
• Width: 150 Millimeter
• Height: 30 Millimeter
• Length: 247 Millimeter
• Width: 150 Millimeter
• Height: 30 Millimeter
• Length: 247 Millimeter
• Width: 150 Millimeter
• Height: 30 Millimeter
• Length: 247 Millimeter
• Width: 150 Millimeter
• Height: 30 Millimeter
• Length: 247 Millimeter
• Width: 150 Millimeter
• Height: 30 Millimeter
• Length: 247 Millimeter
• Width: 150 Millimeter
• Height: 30 Millimeter
• Length: 247 Millimeter
• Width: 150 Millimeter
• Height: 30 Millimeter
• Length: 247 Millimeter
• Width: 150 Millimeter
• Height: 30 Millimeter

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 700 millibar and 1060 millibar

Device Identifiers

Device Issuing Agency	Device ID
GS1	04036616000369 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082655

FDA Product Code

• CCL: Analyzer, Gas, Oxygen, Gaseous-Phase

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-27
• Device Publish Date: 2020-03-03

On-Brand Devices [Oxygen Sensor]

• 04036616012836: OOMLF102-M4
• 04036616010986: OOMLF202-2S
• 04036616010962: OOMLF202-2
• 04036616010955: OOMLF103-1M
• 04036616010948: OOMLF102-M3
• 04036616010931: OOMLF105
• 04036616010917: OOMLF106
• 04036616010870: OOMLF202-1
• 04036616010863: OOMLF202
• 04036616010849: OOMLF111
• 04036616010832: OOMLF110
• 04036616010818: OOMLF103-1
• 04036616010801: OOMLF103
• 04036616010795: OOMLF102-1
• 04036616010788: OOMLF102
• 04036616000536: OOM202-2S
• 04036616000369: Oxygen Sensor OOM102-1
• 04036616000543: Oxygen Sensor OOM204
• 04036616000529: Oxygen Sensor OOM202-2
• 04036616000512: Oxygen Sensor OOM202-1
• 04036616000505: Oxygen Sensor OOM202
• 04036616000499: Oxygen Sensor OOM201
• 04036616000482: Oxygen Sensor OOM110
• 04036616000437: Oxygen Sensor OOM107
• 04036616000420: Oxygen Sensor
• 04036616000413: Oxygen Sensor OOM105
• 04036616000406: Oxygen Sensor OOM104
• 04036616000390: Oxygen Sensor OOM103-1M
• 04036616000383: Oxygen Sensor OOM103-1
• 04036616000376: Oxygen Sensor OOM103
• 04036616000352: Oxygen Sensor OOM102
• 04036616000345: Oxygen Sensor OOM101
• 04036616000307: Oxygen Sensor OOM111
• 04036616013505: OOMLF101-M
• 04036616010900: Oxygen Sensor OOMLF204