MOX4

GUDID B739AA829M200

MOX4, Medical Oxygen sensor

EnviteC-Wismar GmbH

Respiratory oxygen sensor

• Primary Device ID: B739AA829M200
• NIH Device Record Key: b1dcba05-0b1d-4f16-91f1-af11c646f9fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MOX4
• Version Model Number: AA829-M20
• Company DUNS: 330943838
• Company Name: EnviteC-Wismar GmbH
• Device Count: 1
• DM Exempt: true
• 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: false
• Expiration Date: true
• 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: +493841360324
• Email: Christian.Walsleben@honeywell.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B739AA829M200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041773

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: 2020-03-05
• Device Publish Date: 2019-04-09

Devices Manufactured by EnviteC-Wismar GmbH

• 04036616010900 - Oxygen Sensor: 2022-06-27 Oxygen Sensor OOMLF204
• 04036616000581 - Disposable Sensor: 2021-11-10 Disposable Sensor DA-2221-1 BCI
• 04036616000604 - Disposable Sensor: 2021-11-10 Disposable Sensor DA-2251-1 Datex
• 04036616005494 - Disposable Sensor: 2021-11-10 Disposabel Sensor DA-2211-1 Nellcor
• 04036616005982 - Disposable Sensor: 2021-11-10 Disposable Sensor DA-2231-1 Nonin
• 04036616007146 - Disposable Sensor: 2021-11-10 Disposable Sensor DA-2221-1 OEM BCI
• 04036616007214 - Disposable Sensor: 2021-11-10 Disposable Sensor DA-2231-1 OEM Nonin
• 04036616007528 - Disposable Sensor: 2021-11-10 Disposable Sensor DA-2211-1 OEM Nellcor