HeartVue Wrist Blood Pressure Monitor

GUDID 20073796260006

Omron Healthcare, Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 20073796260006
• NIH Device Record Key: 70ca6b94-dce3-494c-ac87-f609aaca3024
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeartVue Wrist Blood Pressure Monitor
• Version Model Number: BP6000
• Company DUNS: 054318779
• Company Name: Omron Healthcare, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-634-4350
• Email: ohiquality@omron.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796260002 [Primary]
GS1	10073796260009 [Package]; Contains: 00073796260002; Package: Case [4 Units]; In Commercial Distribution
GS1	20073796260006 [Package]; Contains: 10073796260009; Package: Master Carton [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163045

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-03-20

Devices Manufactured by Omron Healthcare, Inc.

• 10073796271500 - 3 Series Upper Arm Blood Pressure Monitor: 2024-04-23 Automatic inflation upper arm blood pressure monitor with wide range cuff. (9-17 inch), Bluetooth connectivity, 14 memory storag
• 10073796272552 - Omron 5 Series Upper Arm Blood Pressure Monitor: 2024-04-23 Upper Arm Blood Pressure Monitor w/Bluetooth Connectivity, 30 Memory Storage, Extra Large Display, Irregular Heartbeat Detection
• 10073796423121 - Extra large D-ring Cuff for Telehealth Blood Pressure Monitor: 2022-08-09
• 10073796893108 - Blood Pressure Monitor: 2022-07-11 Telehealth Blood Pressure Monitor with extra large cuff compatibility.
• 00073796930004 - Blood Pressure Monitor: 2022-06-09 Telehealth Blood Pressure Monitor with range cup 9-17 inch.
• 10073796711020 - Omron Upper Arm Blood Pressure Monitor: 2021-09-23 Upper arm blood pressure monitor - One-touch operation - 30 memory storage - irregular heartbeat detection
• 00073796507206 - No-Touch Forehead Thermometer: 2021-09-09 No-touch forehead thermometer with fast 1 second measurement and high temperature notification. 25 memory reading.
• 00073796745530 - Omron Blood Pressure Monitor: 2021-09-09 Blood Pressure Monitor w/Bluetooth, Comparison Display, pre-formed Comfit Cuff, irregular heartbeat detector and 200 memory stor