BodyTrace

GUDID B726BT1042

Upper arm blood pressure monitor.

BODYTRACE, INC

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: B726BT1042
• NIH Device Record Key: e5bfc2ee-0623-4972-8c6e-6680cb935e6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BodyTrace
• Version Model Number: BT104
• Company DUNS: 116841525
• Company Name: BODYTRACE, 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

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B726BT1040 [Primary]
HIBCC	B726BT1041 [Package]; Contains: B726BT1040; Package: Individual box [1 Units]; In Commercial Distribution
HIBCC	B726BT1042 [Package]; Contains: B726BT1041; Package: 5-piece carton [5 Units]; In Commercial Distribution

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: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-04-01

On-Brand Devices [BodyTrace]

• B726BT1042: Upper arm blood pressure monitor.
• B726BT1051: Upper arm blood pressure monitor.
• B726BT0051: Weight scale.
• B726BT1061: Upper arm blood pressure monitor.
• B726BT0061: Weight scale.
• B726BT007B1: Weight scale.
• B726BT007A1: Weight scale.