| Primary Device ID | 00860008537898 |
| NIH Device Record Key | 0c51643d-3cf8-4211-aa63-31c678526d03 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lumicell Direct Visualization System (DVS) |
| Version Model Number | 900-00209 |
| 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 | false |
| Lot Batch | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 1-833-458-6387 |
| support@lumicell.com | |
| Phone | 1-833-458-6387 |
| support@lumicell.com | |
| Phone | 1-833-458-6387 |
| support@lumicell.com | |
| Phone | 1-833-458-6387 |
| support@lumicell.com | |
| Phone | 1-833-458-6387 |
| support@lumicell.com | |
| Phone | 1-833-458-6387 |
| support@lumicell.com | |
| Phone | 1-833-458-6387 |
| support@lumicell.com | |
| Phone | 1-833-458-6387 |
| support@lumicell.com | |
| Phone | 1-833-458-6387 |
| support@lumicell.com | |
| Phone | 1-833-458-6387 |
| support@lumicell.com |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860008537898 [Primary] |
| SAW | Fluorescence Imaging For Breast Cancer Detection |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00860008537898]
Hydrogen Peroxide
[00860008537898]
Hydrogen Peroxide
[00860008537898]
Hydrogen Peroxide
[00860008537898]
Hydrogen Peroxide
[00860008537898]
Hydrogen Peroxide
[00860008537898]
Hydrogen Peroxide
[00860008537898]
Hydrogen Peroxide
[00860008537898]
Hydrogen Peroxide
[00860008537898]
Hydrogen Peroxide
[00860008537898]
Hydrogen Peroxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-27 |
| Device Publish Date | 2024-11-19 |
| 00860008537898 | Sterilization Tray |
| 00860008537829 | Calibration Plate, Disposable |
| 00860003252550 | Handheld Probe |
| 00860003252543 | Workstation Assembly |
| 00860003252598 | Light source |
| 00860003252512 | Sterile Cover |