Omron 10 Series Upper Arm Blood Pressure Monitor BP7450CAN

GUDID 10073796745315

10 Series upper arm blood pressure monitor with Bluetooth, 200 memory, 2 users and TruRead technology

Omron Healthcare, Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 10073796745315
• NIH Device Record Key: 303680c4-51ff-45d9-9a42-7ba1ee157702
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omron 10 Series Upper Arm Blood Pressure Monitor
• Version Model Number: BP7450CAN
• Catalog Number: BP7450CAN
• 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: 800-634-4350
• Email: ohiquality@omron.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796745318 [Primary]
GS1	10073796745315 [Package]; Contains: 00073796745318; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133383

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: 2019-07-08

Devices Manufactured by Omron Healthcare, Inc.

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