Proteus Digital Health Feedback System

GUDID 10856602005137

PROTEUS DIGITAL HEALTH, INC.

Medication adherence telemetric monitoring system, post-ingestion

• Primary Device ID: 10856602005137
• NIH Device Record Key: 7400f3e3-ecd2-4420-bd3e-856b023e689f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Proteus Digital Health Feedback System
• Version Model Number: SPC-2005
• Company DUNS: 149825791
• Company Name: PROTEUS DIGITAL HEALTH, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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	00856602005130 [Primary]
GS1	10856602005137 [Package]; Contains: 00856602005130; Package: [2 Units]; In Commercial Distribution
GS1	20856602005134 [Package]; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150494

FDA Product Code

• OZW: Ingestible event marker

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: 2018-08-02
• Device Publish Date: 2018-07-02

On-Brand Devices [Proteus Digital Health Feedback System]

• 00856602005222: SPC-2330
• 00856602005215: SPC-2329
• 10856602005137: SPC-2005