Omron Gold, Wrist Blood Pressure Monitor BP4350

GUDID 10073796264359

Wrist Blood Pressure - 100 readings per user (2 users), Bluetooth Connectivity, Ultra Silent Inflation.

Omron Healthcare, Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 10073796264359
• NIH Device Record Key: 67733893-039f-4738-b3d6-b539aa894c3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omron Gold, Wrist Blood Pressure Monitor
• Version Model Number: BP4350
• Catalog Number: BP4350
• 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 Humidity: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796264352 [Primary]
GS1	10073796264359 [Package]; Contains: 00073796264352; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182166

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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