Omron Blood Pressure Monitor BP769CAN

GUDID 20073796769318

Digital Upper Arm Blood Pressure Monitor with 9" to 17" Easy-Wrap Cuff

Omron Healthcare, Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 20073796769318
• NIH Device Record Key: 00910eca-e06c-4710-80d1-5af4a575b1d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omron Blood Pressure Monitor
• Version Model Number: BP769CAN
• Catalog Number: BP769CAN
• 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 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00073796769314 [Primary]
GS1	20073796769318 [Package]; Contains: 00073796769314; Package: Case [6 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: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-09-01

On-Brand Devices [Omron Blood Pressure Monitor]

• 20073796769318: Digital Upper Arm Blood Pressure Monitor with 9" to 17" Easy-Wrap Cuff
• 00073796710217: BP710NVA
• 00073796745530: Blood Pressure Monitor w/Bluetooth, Comparison Display, pre-formed Comfit Cuff, irregular heartb