Sunbeam

GUDID 00694501169818

Wrist Cuff Blood Pressure Monitor

Star Elite Inc

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00694501169818
• NIH Device Record Key: e5d2eede-af5b-4998-8729-25ee3be2d1f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sunbeam
• Version Model Number: FT-B06W-V
• Company DUNS: 201197410
• Company Name: Star Elite 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00694501169818 [Primary]
GS1	30694501169819 [Package]; Package: Case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150430

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: 2021-07-09
• Device Publish Date: 2021-07-01

On-Brand Devices [Sunbeam]

• 30694501169857: Upper arm blood pressure monitor intended for use in adults to measure heartbeat rate and blood
• 00694501169818: Wrist Cuff Blood Pressure Monitor
• 00694501169825: HW-F1
• 00694501169801: Deluxe Pulse Oximeter