blood pressure monitor

GUDID 00817746020007

BETTER BASICS, INC.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00817746020007
• NIH Device Record Key: d089c8f9-06d3-45c4-93b0-c6166bfd6c88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: blood pressure monitor
• Version Model Number: MP-BPM20A-US
• Company DUNS: 013029698
• Company Name: BETTER BASICS, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817746020007 [Primary]
GS1	00817746020014 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	00817746020021 [Package]; Contains: 00817746020014; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101681

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: 2016-11-18

On-Brand Devices [blood pressure monitor]

• 00817746020120: MP-BPM80A-US
• 00817746020090: MP-BPMA70-US
• 00817746020069: MP-BPMW60-US
• 00817746020038: MP-BPM50W-US
• 00817746020007: MP-BPM20A-US