ANNE Chest

GUDID 00860004541745

The ANNE Chest is a wearable, wireless sensor intended for the measurement of ECG waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature.

Sibel Health Inc.

Wearable multiple vital physiological parameter monitor

• Primary Device ID: 00860004541745
• NIH Device Record Key: 456ed166-dd66-4669-9e18-8ac08b802855
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANNE Chest
• Version Model Number: 810-00012
• Company DUNS: 093772547
• Company Name: Sibel Health 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: true
• Serial Number: true
• Manufacturing Date: true
• 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	00860004541745 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240251

FDA Product Code

• BZQ: Monitor, Breathing Frequency

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: 2025-04-10
• Device Publish Date: 2025-04-02

Devices Manufactured by Sibel Health Inc.

• 00850064210200 - Sibel Spacelabs Trek Chest Patch: 2025-04-10
• 00850064210217 - Sibel Spacelabs Trek Finger Patch: 2025-04-10
• 00850064210224 - Sibel Spacelabs Trek Charger: 2025-04-10
• 00850064210231 - Sibel Spacelabs Finger Patch Adhesive 3 day: 2025-04-10
• 00850064210248 - Sibel Spacelabs Trek Chest Patch Adhesive: 2025-04-10
• 00850064210255 - Sibel Spacelabs Trek Blood Pressure Cuff: 2025-04-10
• 00850064210262 - Sibel Spacelabs Trek Tablet: 2025-04-10
• 00860004541745 - ANNE Chest: 2025-04-10The ANNE Chest is a wearable, wireless sensor intended for the measurement of ECG waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature.
• 00860004541745 - ANNE Chest: 2025-04-10 The ANNE Chest is a wearable, wireless sensor intended for the measurement of ECG waveforms, heart rate, respiratory rate, activ