NightOwl

GUDID 05430001742022

NightOwl sensor kit.

Ectosense

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: 05430001742022
• NIH Device Record Key: 08984f6a-d7e6-4351-aca4-aa707115ddeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NightOwl
• Version Model Number: 01.00
• Company DUNS: 371024503
• Company Name: Ectosense
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05430001742022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191031

FDA Product Code

• MNR: Ventilatory Effort Recorder

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: 2023-06-02
• Device Publish Date: 2020-06-12

On-Brand Devices [NightOwl]

• 05430001742039: Mini
• 05430001742022: NightOwl sensor kit.