Omron AAA-80013

GUDID 08624920003143

Optum Home BP I-Apollo

OPTUMHEALTH CARE SOLUTIONS, INC.

Self-care monitoring/reporting software

• Primary Device ID: 08624920003143
• NIH Device Record Key: d97ed9f2-a4a1-474f-ac39-76331e3de297
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omron
• Version Model Number: HEM9200T
• Catalog Number: AAA-80013
• Company DUNS: 078270206
• Company Name: OPTUMHEALTH CARE SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08624920003143 [Primary]

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: 2020-06-03
• Device Publish Date: 2020-05-26

On-Brand Devices [Omron]

• 08624920003143: Optum Home BP I-Apollo
• 08624920003129: Optum Home BP II-Apollo
• 08624920003082: Optum Homecare LG W/BP