BlackBox

GUDID B963101C1

Cellular Blood Pressure Monitor

Blackbox Remote Patient Monitoring LLC

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: B963101C1
• NIH Device Record Key: 13cdb044-a606-42cc-96e0-a63e3ddabb89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BlackBox
• Version Model Number: BPM-101C
• Company DUNS: 117652799
• Company Name: Blackbox Remote Patient Monitoring LLC
• 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: 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
HIBCC	B963101C1 [Primary]
HIBCC	BB1BB963101C1 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[B963101C1]

High-level Disinfectant

[B963101C1]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-19
• Device Publish Date: 2020-10-10

On-Brand Devices [BlackBox]

• B963101C1: Cellular Blood Pressure Monitor
• BB4B963WS501C1: Cellular weight scale with a large platform and high weight capacity