ANNE Sleep

GUDID 00860004541714

ANNE Sleep is a wearable sensor system intended for use in the collection, analysis, display, and storage of physiological parameters to aid in the diagnosis of sleep-related breathing disorders by healthcare professionals.

Sibel Inc.

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• Primary Device ID: 00860004541714
• NIH Device Record Key: a8884614-e794-4a3c-8bfe-2e023197989f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANNE Sleep
• Version Model Number: SA-008
• Company DUNS: 093772547
• Company Name: Sibel 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860004541714 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220095

FDA Product Code

• MNR: Ventilatory Effort Recorder

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: 2022-07-28
• Device Publish Date: 2022-07-20

Devices Manufactured by Sibel Inc.

• 00860004541714 - ANNE Sleep: 2022-07-28ANNE Sleep is a wearable sensor system intended for use in the collection, analysis, display, and storage of physiological parameters to aid in the diagnosis of sleep-related breathing disorders by healthcare professionals.
• 00860004541714 - ANNE Sleep: 2022-07-28 ANNE Sleep is a wearable sensor system intended for use in the collection, analysis, display, and storage of physiological param
• 00860004541707 - ANNE™ One: 2021-10-28 ANNE One is a wireless vital signs and physiological data monitoring platform that streams real-time biosignals including electr