| Primary Device ID | 00850003892054 |
| NIH Device Record Key | 7179050a-2c2e-4d0a-814c-4fc71f242993 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OptiScanner 5000 Disposable Cartridge |
| Version Model Number | 5000 |
| Company DUNS | 939218384 |
| Company Name | OPTISCAN BIOMEDICAL CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 510.342.5818 |
| edeperalta@optiscancorp.com | |
| Phone | 510.342.5818 |
| edeperalta@optiscancorp.com | |
| Phone | 510.342.5818 |
| edeperalta@optiscancorp.com | |
| Phone | 510.342.5818 |
| edeperalta@optiscancorp.com | |
| Phone | 510.342.5818 |
| edeperalta@optiscancorp.com | |
| Phone | 510.342.5818 |
| edeperalta@optiscancorp.com | |
| Phone | 510.342.5818 |
| edeperalta@optiscancorp.com | |
| Phone | 510.342.5818 |
| edeperalta@optiscancorp.com | |
| Phone | 510.342.5818 |
| edeperalta@optiscancorp.com | |
| Phone | 510.342.5818 |
| edeperalta@optiscancorp.com | |
| Phone | 510.342.5818 |
| edeperalta@optiscancorp.com | |
| Phone | 510.342.5818 |
| edeperalta@optiscancorp.com | |
| Phone | 510.342.5818 |
| edeperalta@optiscancorp.com | |
| Phone | 510.342.5818 |
| edeperalta@optiscancorp.com |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to rain or water |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to rain or water |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to rain or water |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to rain or water |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to rain or water |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to rain or water |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to rain or water |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to rain or water |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to rain or water |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to rain or water |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to rain or water |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to rain or water |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to rain or water |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850003892054 [Primary] |
| GS1 | 10850003892051 [Package] Package: Box [1 Units] In Commercial Distribution |
| GS1 | 20850003892058 [Package] Contains: 10850003892051 Package: Carton [5 Units] In Commercial Distribution |
| PYV | Hospital Continuous Glucose Monitoring System |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00850003892054]
Radiation Sterilization
[00850003892054]
Radiation Sterilization
[00850003892054]
Radiation Sterilization
[00850003892054]
Radiation Sterilization
[00850003892054]
Radiation Sterilization
[00850003892054]
Radiation Sterilization
[00850003892054]
Radiation Sterilization
[00850003892054]
Radiation Sterilization
[00850003892054]
Radiation Sterilization
[00850003892054]
Radiation Sterilization
[00850003892054]
Radiation Sterilization
[00850003892054]
Radiation Sterilization
[00850003892054]
Radiation Sterilization
[00850003892054]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-01-31 |
| Device Publish Date | 2018-12-31 |
| 00850003892054 - OptiScanner 5000 Disposable Cartridge | 2019-01-31OptiScanner Disposable Cartridge |
| 00850003892054 - OptiScanner 5000 Disposable Cartridge | 2019-01-31 OptiScanner Disposable Cartridge |
| 00850003892504 - OptiScanner 5000 Glucose Monitoring System | 2019-01-31 Automated, in-line, bedside, glucose monitoring system |