Omron Platinum Upper Arm Blood Pressure Monitor BP5450

GUDID 10073796265455

Omron automatic digital upper arm blood pressure monitor. Two users with 100 readings of memory storage per user. Bluetooth connectivity.

Omron Healthcare, Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 10073796265455
• NIH Device Record Key: 8d8ee005-7762-4fdc-8b96-64aa2decd971
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omron Platinum Upper Arm Blood Pressure Monitor
• Version Model Number: BP5450
• Catalog Number: BP5450
• 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

• Storage Environment Humidity: Between 10 millibar and 90 millibar

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796265458 [Primary]
GS1	10073796265455 [Package]; Contains: 00073796265458; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133379

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: 2019-07-01

Devices Manufactured by Omron Healthcare, Inc.

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• 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.