Omron Heart Guide Wrist Blood Pressure Monitor, Large BP8000-L

GUDID 20073796268026

Wearable Wrist Blood Pressure Monitor with Fitness and Sleep Tracking

Omron Healthcare, Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 20073796268026
• NIH Device Record Key: 4b0a84c8-6e93-4c7a-b554-e1948ad8d934
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omron Heart Guide Wrist Blood Pressure Monitor, Large
• Version Model Number: BP8000-L
• Catalog Number: BP8000-L
• 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: true
• 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 Humidity: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796268022 [Primary]
GS1	10073796268029 [Package]; Contains: 00073796268022; Package: Inner Carton [4 Units]; In Commercial Distribution
GS1	20073796268026 [Package]; Contains: 10073796268029; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190693

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: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-09-13

Devices Manufactured by Omron Healthcare, Inc.

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• 10073796251502 - Bronze Upper Arm Blood Pressure Monitor: 2024-05-23 Upper Arm Blood Pressure Monitor Automatic Inflation with wide range cuff, and 14 memory readings.
• 10073796252554 - Silver Upper Arm Blood Pressure Monitor: 2024-05-23 Upper Arm Blood Pressure Monitor w/Bluetooth Connectivity, 30 Reading Memory, Easy Wrap ComFit Cuff
• 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.