MATRx plus

GUDID B406CAT024020

Zephyr Sleep Technologies Inc

Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system Home-use sleep apnoea recording system

• Primary Device ID: B406CAT024020
• NIH Device Record Key: c7692ea6-3c6b-4928-982c-11295dd91d96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MATRx plus
• Version Model Number: MATRx plus CAT-024-02
• Company DUNS: 245252833
• Company Name: Zephyr Sleep Technologies Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-877-341-8814
• Email: support@zephyrsleep.com
• Phone: 1-877-341-8814
• Email: support@zephyrsleep.com
• Phone: 1-877-341-8814
• Email: support@zephyrsleep.com
• Phone: 1-877-341-8814
• Email: support@zephyrsleep.com
• Phone: 1-877-341-8814
• Email: support@zephyrsleep.com
• Phone: 1-877-341-8814
• Email: support@zephyrsleep.com
• Phone: 1-877-341-8814
• Email: support@zephyrsleep.com
• Phone: 1-877-341-8814
• Email: support@zephyrsleep.com
• Phone: 1-877-341-8814
• Email: support@zephyrsleep.com
• Phone: 1-877-341-8814
• Email: support@zephyrsleep.com
• Phone: 1-877-341-8814
• Email: support@zephyrsleep.com
• Phone: 1-877-341-8814
• Email: support@zephyrsleep.com
• Phone: 1-877-341-8814
• Email: support@zephyrsleep.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B406CAT024020 [Primary]

FDA Product Code

• QCJ: Closed Loop Auto Titration Device For Oral Appliances

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: 2019-05-24
• Device Publish Date: 2019-05-16

On-Brand Devices [MATRx plus]

• B406CAT024010: MATRx plus CAT-024-01
• B406CAT024020: MATRx plus CAT-024-02
• B406CAT024030: MATRx plus CAT-024-03