ANNE Limb Sensor

GUDID 00850064210156

Sibel Health Inc.

Wearable multiple physiological parameter recorder, reusable

• Primary Device ID: 00850064210156
• NIH Device Record Key: 919bd494-ce4c-45f0-984b-be2cfefc6f09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANNE Limb Sensor
• Version Model Number: 810-00013
• Company DUNS: 093772547
• Company Name: Sibel Health Inc.
• 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: 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	00850064210156 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240305

FDA Product Code

• DQA: Oximeter

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.

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• 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