BlackBox RPM

GUDID BB4B963PO401W1

Pulse Oximeter

Blackbox Remote Patient Monitoring LLC

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• Primary Device ID: BB4B963PO401W1
• NIH Device Record Key: 74eb60f4-4dc4-4af2-9526-6862ff02b877
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BlackBox RPM
• Version Model Number: PO-401W
• 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	B963PO401W1 [Primary]
HIBCC	BB4B963PO401W1 [Package]; Contains: B963PO401W1; Package: Cartons [136 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120502

FDA Product Code

• DQA: Oximeter

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: 2020-10-28
• Device Publish Date: 2020-10-20

On-Brand Devices [BlackBox RPM]

• B963BPM201W1: Blood Pressure monitor designed to be used seamlessly with our proprietary hub or mobile app.
• BB4B963PO401W1: Pulse Oximeter
• B963102C1: Cellular Blood Pressure monitor