Ozeri BP9W

GUDID 00815817013293

COMMONPATH LLC

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00815817013293
• NIH Device Record Key: aed7eede-25d1-490f-8134-d87b046aabaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ozeri
• Version Model Number: BP9W
• Catalog Number: BP9W
• Company DUNS: 963223677
• Company Name: COMMONPATH LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• 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

Customer Support Contacts

• Phone: 18772991296
• Email: support@ozeri.com
• Phone: 18772991296
• Email: support@ozeri.com
• Phone: 18772991296
• Email: support@ozeri.com
• Phone: 18772991296
• Email: support@ozeri.com
• Phone: 18772991296
• Email: support@ozeri.com
• Phone: 18772991296
• Email: support@ozeri.com
• Phone: 18772991296
• Email: support@ozeri.com
• Phone: 18772991296
• Email: support@ozeri.com
• Phone: 18772991296
• Email: support@ozeri.com
• Phone: 18772991296
• Email: support@ozeri.com
• Phone: 18772991296
• Email: support@ozeri.com
• Phone: 18772991296
• Email: support@ozeri.com
• Phone: 18772991296
• Email: support@ozeri.com
• Phone: 18772991296
• Email: support@ozeri.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815817013293 [Primary]
GS1	10815817013290 [Package]; Package: Giftbox [1 Units]; In Commercial Distribution
GS1	20815817013297 [Package]; Contains: 10815817013290; Package: Carton box [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160019

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-14
• Device Publish Date: 2020-08-06

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• 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
• 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