GUDID 10856602005106

PROTEUS DIGITAL HEALTH, INC.

Medication adherence telemetric monitoring system ingestible transmitter

• Primary Device ID: 10856602005106
• NIH Device Record Key: bd850b8c-818f-4a19-8c0b-d530ad7f3c76
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SPC-1330.B55
• Company DUNS: 149825791
• Company Name: PROTEUS DIGITAL HEALTH, INC.
• Device Count: 250
• 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	00856602005109 [Unit of Use]
GS1	10856602005106 [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
• 10856602005106 - NA: 2022-11-28
• 10856602005106 - NA: 2022-11-28