A&D AAA-80013

GUDID 00862492000339

Optum Home BP I-Apollo

OPTUMHEALTH CARE SOLUTIONS, INC.

Self-care monitoring/reporting software

• Primary Device ID: 00862492000339
• NIH Device Record Key: afdafdaf-1868-4a94-a85d-b5a3f948a844
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A&D
• Version Model Number: UA651BLE
• 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: MR Conditional
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862492000339 [Primary]

FDA Product Code

• DXN: System, measurement, blood-pressure, non-invasive

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: 2020-12-15
• Device Publish Date: 2020-12-07

On-Brand Devices [A&D]

• 00862492000346: Optum Homecare Portal W/BP
• 00862492000339: Optum Home BP I-Apollo