Ozeri

GUDID 20815817012450

BP8H Blood pressure monitor with ARM CUFF

COMMONPATH LLC

Automatic-inflation electronic sphygmomanometer, portable, finger Automatic-inflation electronic sphygmomanometer, portable, finger Automatic-inflation electronic sphygmomanometer, portable, finger

• Primary Device ID: 20815817012450
• NIH Device Record Key: 99d0c2b6-d51c-4f26-b6a5-9f8f08fbed0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ozeri
• Version Model Number: BP8H
• Company DUNS: 963223677
• Company Name: COMMONPATH LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815817012456 [Primary]
GS1	10815817012453 [Package]; Contains: 00815817012456; Package: Box [1 Units]; Discontinued: 2017-05-15; Not in Commercial Distribution
GS1	20815817012450 [Package]; Contains: 10815817012453; Package: Carton box [10 Units]; Discontinued: 2017-05-15; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123600

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: 2017-05-15

On-Brand Devices [Ozeri ]

• 00815817012333: Bathroom scale body fat analyzer. Support up to 8 users. Scale supports TARE function. Default
• 00815817012326: Default unit is LB. Batteries included. Utilizes 4 high precision GX sensors to weigh up to 44
• 70000010001002: Bathroom scale body fat analyzer. Support up to 8 users. Scale supports TARE function. Default
• 70000010001001: Bathroom scale body fat analyzer. Support up to 8 users. Scale supports TARE function. Default
• 20815817012740: BP3T Blood pressure monitor with ARM CUFF Advanced one-step operation. Push-Button access to av
• 20815817012689: Ozeri Cardio Tech, Travel series. LEss than 1" inch(2.5cm) thick and 3.5 oz(100g). New MWI(Mea
• 20815817012450: BP8H Blood pressure monitor with ARM CUFF
• 20815817013259: BP3T Blood pressure monitor with ARM CUFF Advanced one-step operation. Push-Button access to av
• 00815817013293: BP9W
• 10815817013481: The Thermometer can display the result in either Fahrenheit or degree Celsius. How to use: Ste
• 10815817013306: Travel series BPM. LEss than 1" inch(2.5cm) thick and 3.5 oz(100g). New MWI(Measure white infl
• 10815817014150: The Thermometer can display the result in either Fahrenheit or degree Celsius. Colour - Black