True Integral

GUDID 00860001532739

TRUE INTEGRAL INC

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00860001532739
• NIH Device Record Key: 39aa787a-c1ba-4275-870a-e42ce266a83b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: True Integral
• Version Model Number: B02
• Company DUNS: 117033737
• Company Name: TRUE INTEGRAL 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001532739 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172171

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: 2019-04-24

On-Brand Devices [True Integral]

• 00860001532760: Upper Arm Blood Pressure Monitor
• 00860001532753: Digital thermometer
• 00860001532746: Dual mode thermometer
• 00860001532739: B02
• 00860001532708: B05
• 00860001532777: Digital thermometer
• 00860003079706: Intelligent Mesh Nebulizer
• 00860003079737: UPER ARM BLOOD PRESSURE MONITOR
• 00860003079713: INFRARED FOREHEAD THERMOMETER
• 00860003079744: UPER ARM BLOOD PRESSURE MONITOR
• 00860003079720: No- contact infarared body thermometer