MOBI

GUDID 10891040000276

Bluetooth Blood Pressure Monitor

MOBI TECHNOLOGIES, INC.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 10891040000276
• NIH Device Record Key: bfbfc7d6-5546-4ed1-8702-e5f5e3d2e3a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MOBI
• Version Model Number: 700027
• Company DUNS: 137468570
• Company Name: MOBI TECHNOLOGIES, 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00891040000279 [Primary]
GS1	10891040000276 [Package]; Contains: 00891040000279; Package: Cardboard [6 Units]; In Commercial Distribution
GS1	20891040000273 [Package]; Package: Cardboard [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182495

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: 2022-08-08
• Device Publish Date: 2022-07-31

On-Brand Devices [MOBI]

• 20891040701002: MOBI Prime3 Ear Thermometer
• 20891040701675: MOBI Health Wrist Blood Pressure Monitor (Sphygmomanometers)
• 20891040702542: MOBI Health Arm Blood Pressure Monitor (Sphygmomanometers)
• 20891040701187: MOBI Air Non-Contact Digital Thermometer
• 20891040701132: Non-Contact Thermometer
• 10891040701111: Oral Digital Thermometer
• 10891040702033: Ultra Pulse Digital Thermometer
• 20891040701217: Prime Ear and Forehead Thermometer.
• 20891040701200: Ultra Pulse Digital Thermometer
• 10891040701197: 70119
• 00891040701251: DualScan Health Check Ear and Forehead Thermometer with Medication Reminder
• 10891040702996: MOBI’s Fingertip Pulse Oximeter offers a noninvasive method for monitoring oxygen salutation.
• 10891040701173: Air Non-Contact Forehead Thermometer
• 10891040000306: Smart Finger Tip Pulse Oximeter
• 10891040000276: Bluetooth Blood Pressure Monitor
• 10891040000269: Smart DualScan Ear + Forehead Bluetooth Thermometer