Oxygen Sensor E1002857

GUDID 04036616013505

EnviteC-Wismar GmbH

Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor

• Primary Device ID: 04036616013505
• NIH Device Record Key: 010240e0-68be-4012-97af-33436f719f14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oxygen Sensor
• Version Model Number: OOMLF101-M
• Catalog Number: E1002857
• 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: +493841360313
• Email: marko.sproessel@honeywell.com
• Phone: +493841360313
• Email: marko.sproessel@honeywell.com
• Phone: +493841360313
• Email: marko.sproessel@honeywell.com
• Phone: +493841360313
• Email: marko.sproessel@honeywell.com
• Phone: +493841360313
• Email: marko.sproessel@honeywell.com
• Phone: +493841360313
• Email: marko.sproessel@honeywell.com
• Phone: +493841360313
• Email: marko.sproessel@honeywell.com
• Phone: +493841360313
• Email: marko.sproessel@honeywell.com
• Phone: +493841360313
• Email: marko.sproessel@honeywell.com
• Phone: +493841360313
• Email: marko.sproessel@honeywell.com
• Phone: +493841360313
• Email: marko.sproessel@honeywell.com
• Phone: +493841360313
• Email: marko.sproessel@honeywell.com
• Phone: +493841360313
• Email: marko.sproessel@honeywell.com
• Phone: +493841360313
• Email: marko.sproessel@honeywell.com
• Phone: +493841360313
• Email: marko.sproessel@honeywell.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04036616013505 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-11
• Device Publish Date: 2021-05-03

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