ANNE Link Mobile

GUDID 00850064210286

Sibel Health Inc.

Self-care monitoring/reporting software

• Primary Device ID: 00850064210286
• NIH Device Record Key: a99990af-8388-414f-9e49-2341fe340040
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANNE Link Mobile
• Version Model Number: 900-00069
• Company DUNS: 093772547
• Company Name: Sibel Health Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850064210286 [Primary]

FDA Product Code

• OUG: Medical Device Data System

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: 2025-12-19
• Device Publish Date: 2025-12-11

Devices Manufactured by Sibel Health Inc.

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