ANNE Chest Sensor Kit

GUDID 00850064210002

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: 00850064210002
• NIH Device Record Key: 9c54778b-d805-4d50-986d-18be78a9aec3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANNE Chest Sensor Kit
• Version Model Number: 900-00007
• 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: 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	00850064210002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240251

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: 2025-04-03
• Device Publish Date: 2025-03-26

Devices Manufactured by Sibel Health Inc.

• 00850064210286 - ANNE Link Mobile: 2025-12-19
• 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