Equate Premium BP Monitor UA-8500WM

GUDID 00681131247887

Upper Arm Premium Digital Blood Pressure Monitor

WAL-MART STORES, INC.

Automatic-inflation electronic sphygmomanometer, non-portable

• Primary Device ID: 00681131247887
• NIH Device Record Key: 4f81b9ff-47e6-4373-b80f-a2c3e3bb75a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Equate Premium BP Monitor
• Version Model Number: 8500 Series
• Catalog Number: UA-8500WM
• Company DUNS: 051957769
• Company Name: WAL-MART STORES, INC.
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681131247887 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163683

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: 3
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-09-26

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