Omron Silver Upper Arm Blood Pressure Monitor BP5250

GUDID 00073796265250

Omron automatic digital upper arm blood pressure monitor with 80 reading memory storage. Bluetooth connectivity.

Omron Healthcare, Inc.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00073796265250
• NIH Device Record Key: ae2924f8-0aec-4b22-8994-cf5aa23c4fbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omron Silver Upper Arm Blood Pressure Monitor
• Version Model Number: BP5250
• Catalog Number: BP5250
• 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	00073796265250 [Primary]

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: 2019-07-01

Devices Manufactured by Omron Healthcare, Inc.

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