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 |