Omada

GUDID B726BT104O2

Upper arm blood pressure monitor.

BODYTRACE, INC

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: B726BT104O2
• NIH Device Record Key: 0ec46893-b26e-4db0-a4f2-9901f5482402
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omada
• Version Model Number: BT104O
• 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	B726BT104O0 [Primary]
HIBCC	B726BT104O1 [Package]; Contains: B726BT104O0; Package: Individual box [1 Units]; In Commercial Distribution
HIBCC	B726BT104O2 [Package]; Contains: B726BT104O1; 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 [Omada]

• B726BT104O2: Upper arm blood pressure monitor.
• B726BT105O1: Upper arm blood pressure monitor.
• B726BT005O1: Weight scale.