OptiScanner 5000 Disposable Cartridge

GUDID 00850003892054

OptiScanner Disposable Cartridge

OPTISCAN BIOMEDICAL CORPORATION

Point-of-care blood glucose continuous monitoring system
Primary Device ID00850003892054
NIH Device Record Key7179050a-2c2e-4d0a-814c-4fc71f242993
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptiScanner 5000 Disposable Cartridge
Version Model Number5000
Company DUNS939218384
Company NameOPTISCAN BIOMEDICAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone510.342.5818
Emailedeperalta@optiscancorp.com
Phone510.342.5818
Emailedeperalta@optiscancorp.com
Phone510.342.5818
Emailedeperalta@optiscancorp.com
Phone510.342.5818
Emailedeperalta@optiscancorp.com
Phone510.342.5818
Emailedeperalta@optiscancorp.com
Phone510.342.5818
Emailedeperalta@optiscancorp.com
Phone510.342.5818
Emailedeperalta@optiscancorp.com
Phone510.342.5818
Emailedeperalta@optiscancorp.com
Phone510.342.5818
Emailedeperalta@optiscancorp.com
Phone510.342.5818
Emailedeperalta@optiscancorp.com
Phone510.342.5818
Emailedeperalta@optiscancorp.com
Phone510.342.5818
Emailedeperalta@optiscancorp.com
Phone510.342.5818
Emailedeperalta@optiscancorp.com
Phone510.342.5818
Emailedeperalta@optiscancorp.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to rain or water
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to rain or water
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to rain or water
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to rain or water
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to rain or water
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to rain or water
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to rain or water
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to rain or water
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to rain or water
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to rain or water
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to rain or water
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to rain or water
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to rain or water
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850003892054 [Primary]
GS110850003892051 [Package]
Package: Box [1 Units]
In Commercial Distribution
GS120850003892058 [Package]
Contains: 10850003892051
Package: Carton [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PYVHospital Continuous Glucose Monitoring System

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[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


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-31
Device Publish Date2018-12-31

Devices Manufactured by OPTISCAN BIOMEDICAL CORPORATION

00850003892054 - OptiScanner 5000 Disposable Cartridge2019-01-31OptiScanner Disposable Cartridge
00850003892054 - OptiScanner 5000 Disposable Cartridge2019-01-31 OptiScanner Disposable Cartridge
00850003892504 - OptiScanner 5000 Glucose Monitoring System2019-01-31 Automated, in-line, bedside, glucose monitoring system

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