Omron Gold Upper Arm Blood Pressure Monitor BP5350

GUDID 00073796265359

Omron automatic digital upper arm blood pressure monitor. Two users with 60 readings of memory storage per user. Bluetooth connectivity.

Omron Healthcare, Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00073796265359
• NIH Device Record Key: 2f4b9e11-33c8-4839-872e-94d9a3456f2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omron Gold Upper Arm Blood Pressure Monitor
• Version Model Number: BP5350
• Catalog Number: BP5350
• 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 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796265359 [Primary]
GS1	10073796265356 [Package]; 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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• 00073796254650 - Platinum Upper Arm Blood Pressure Monitor: 2025-02-03 Platinum Upper Arm Blood Pressure Monitor with Wide-Range D-Ring Cuff, 100 memory readings with blue tooth connectivity, 2 user
• 00073796273606 - 7 Series Upper Arm Blood Pressure Monitor: 2025-01-08 7 Series Upper Arm Blood Pressure Monitor with Easy-Wrap ComFit Cuff, 60 memory readings, with blue tooth connectivity, 2 user m
• 00073796274658 - 10 Series Upper Arm Blood Pressure Monitor: 2025-01-08 10 Series Upper Arm Blood Pressure Monitor with Easy-Wrap ComFit Cuff, 100 memory readings, with blue tooth connectivity, 2 user
• 10073796250000 - Iron Upper Arm Blood Pressure Monitor: 2024-05-23 Upper Arm Blood pressure monitor, automatic inflation, wide range D-ring cuff 9"-17" inches.
• 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