EmbraceMini EMBM-1G-SB-B

GUDID 00853858006713

EMPATICA SRL

Multiple vital physiological parameter monitoring system, clinical

• Primary Device ID: 00853858006713
• NIH Device Record Key: b0b0e150-ece4-4ef2-b4f1-5890c0f68bb6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EmbraceMini
• Version Model Number: EmbraceMini stretchable band
• Catalog Number: EMBM-1G-SB-B
• Company DUNS: 430141750
• Company Name: EMPATICA SRL
• 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	00853858006713 [Primary]

FDA Product Code

• LEL: Device, Sleep Assessment

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: 2026-02-24
• Device Publish Date: 2026-02-16

On-Brand Devices [EmbraceMini]

• 00853858006713: EmbraceMini stretchable band
• 00853858006522: EmbraceMini FKM band