GUDID 10856602005090

PROTEUS DIGITAL HEALTH, INC.

Medication adherence telemetric monitoring system ingestible transmitter Medication adherence telemetric monitoring system ingestible transmitter Medication adherence telemetric monitoring system ingestible transmitter Medication adherence telemetric monitoring system ingestible transmitter Medication adherence telemetric monitoring system ingestible transmitter Medication adherence telemetric monitoring system ingestible transmitter Medication adherence telemetric monitoring system ingestible transmitter Medication adherence telemetric monitoring system ingestible transmitter Medication adherence telemetric monitoring system ingestible transmitter Medication adherence telemetric monitoring system ingestible transmitter Medication adherence telemetric monitoring system ingestible transmitter

• Primary Device ID: 10856602005090
• NIH Device Record Key: 2baf8184-c529-4ad7-ba1b-16c7a8f04703
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SPC-1330.B02
• Company DUNS: 149825791
• Company Name: PROTEUS DIGITAL HEALTH, INC.
• Device Count: 2
• 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: false
• 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	00856602005093 [Unit of Use]
GS1	10856602005090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133263

FDA Product Code

• OZW: Ingestible event marker

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-11-28
• Device Publish Date: 2016-09-22

Devices Manufactured by PROTEUS DIGITAL HEALTH, INC.

• 10856602005021 - NA: 2022-11-28
• 10856602005045 - NA: 2022-11-28
• 10856602005052 - NA: 2022-11-28
• 10856602005069 - NA: 2022-11-28
• 10856602005076 - NA: 2022-11-28
• 10856602005083 - NA: 2022-11-28
• 10856602005090 - NA: 2022-11-28
• 10856602005090 - NA: 2022-11-28
• 10856602005106 - NA: 2022-11-28