Lumicell Direct Visualization System (DVS)

GUDID 00860008537829

Calibration Plate, Disposable

Lumicell, Inc.

Intraoperative tumour margin fluorescence imaging system probe calibrator

• Primary Device ID: 00860008537829
• NIH Device Record Key: ceb38675-0974-44e8-abda-9a538127fbfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumicell Direct Visualization System (DVS)
• Version Model Number: 810-00214
• Company DUNS: 832329788
• Company Name: Lumicell, 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: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-833-458-6387
• Email: support@lumicell.com
• Phone: 1-833-458-6387
• Email: support@lumicell.com
• Phone: 1-833-458-6387
• Email: support@lumicell.com
• Phone: 1-833-458-6387
• Email: support@lumicell.com
• Phone: 1-833-458-6387
• Email: support@lumicell.com
• Phone: 1-833-458-6387
• Email: support@lumicell.com
• Phone: 1-833-458-6387
• Email: support@lumicell.com
• Phone: 1-833-458-6387
• Email: support@lumicell.com
• Phone: 1-833-458-6387
• Email: support@lumicell.com
• Phone: 1-833-458-6387
• Email: support@lumicell.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 82.4 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 82.4 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 82.4 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 82.4 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 82.4 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 82.4 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 82.4 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 82.4 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 82.4 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 82.4 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003252567 [Primary]
GS1	00860008537829 [Package]; Contains: 10860003252564; Package: [2 Units]; In Commercial Distribution
GS1	10860003252564 [Package]; Contains: 00860003252567; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P230014

FDA Product Code

• SAW: Fluorescence Imaging For Breast Cancer Detection

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-27
• Device Publish Date: 2024-11-19

On-Brand Devices [Lumicell Direct Visualization System (DVS)]

• 00860008537898: Sterilization Tray
• 00860008537829: Calibration Plate, Disposable
• 00860003252550: Handheld Probe
• 00860003252543: Workstation Assembly
• 00860003252598: Light source
• 00860003252512: Sterile Cover