BPMS Evolution BCE53151

GUDID B970BCE531510

Includes 1 Evolution Handle, BPMS Clinical Software CD with Sensor Map corresponding to Sensor 5315, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (2) 5315 Sensors with Sensor Cover, and 1 Web-Based Training Session (USA Only)

Tekscan, Inc.

Pressure measurement/mapping system, anatomical

• Primary Device ID: B970BCE531510
• NIH Device Record Key: daadd4fc-16b5-40dd-bd39-3acb49bd915f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BPMS Evolution
• Version Model Number: BPMS 1 System (5315 Sensors)
• Catalog Number: BCE53151
• Company DUNS: 178180246
• Company Name: Tekscan, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B970BCE531510 [Primary]

FDA Product Code

• JFC: System, Pressure Measurement, Intermittent

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: 2020-10-22
• Device Publish Date: 2020-10-14

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• B97030101250 - F-Scan GO 3010 Sensor: 2023-12-07 3010, Matrix Sensor, 125psi
• B970BCE531510 - BPMS Evolution: 2020-10-22Includes 1 Evolution Handle, BPMS Clinical Software CD with Sensor Map corresponding to Sensor 5315, Help File and PDF of System Manual, System Carrying Case, Sensor Carrying Case, (2) 5315 Sensors with Sensor Cover, and 1 Web-Based Training Session (USA Only)
• B970BCE531510 - BPMS Evolution: 2020-10-22 Includes 1 Evolution Handle, BPMS Clinical Software CD with Sensor Map corresponding to Sensor 5315, Help File and PDF of System