ANNE™ One

GUDID 00860004541707

ANNE One is a wireless vital signs and physiological data monitoring platform that streams real-time biosignals including electrocardiography, acceleration, and temperature to measure vital signs such as heart rate, respiratory rate, body temperature, skin temperature, step count, and fall count. The system features two skin-mounted, bio-integrated sensors that pair with an associated proprietary software application for the display of real-time vital sign measurements.

Sibel Inc.

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• Primary Device ID: 00860004541707
• NIH Device Record Key: 67565111-0618-4cf4-ab73-36de00979dfa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANNE™ One
• Version Model Number: SA-002
• 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: true
• 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	00860004541707 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211305

FDA Product Code

• DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency

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: 2021-10-28
• Device Publish Date: 2021-10-20

Devices Manufactured by Sibel Inc.

• 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: 2021-10-28ANNE One is a wireless vital signs and physiological data monitoring platform that streams real-time biosignals including electrocardiography, acceleration, and temperature to measure vital signs such as heart rate, respiratory rate, body temperature, skin temperature, step count, and fall count. The system features two skin-mounted, bio-integrated sensors that pair with an associated proprietary software application for the display of real-time vital sign measurements.
• 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