Home GUDID 00850003892054 OptiScanner 5000 Disposable Cartridge
Primary DI 00850003892054
Brand OptiScanner 5000 Disposable Cartridge
Company OPTISCAN BIOMEDICAL CORPORATION
Model 5000
Device description OptiScanner Disposable Cartridge
Published 2018-12-31
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name LZF Pump, Infusion, Analytical Sampling PYV Hospital Continuous Glucose Monitoring System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LZF Pump, Infusion, Analytical Sampling General Hospital 2 PYV Hospital Continuous Glucose Monitoring System Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10850003892051 Package GS1 1 In Commercial Distribution 20850003892058 Package GS1 5 In Commercial Distribution 00850003892054 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10850003892051 10850003892051 20850003892058 20850003892058 00850003892054 00850003892054 850003892054 0850003892054
GMDN Terms# Term, Definition table Term Definition Point-of-care blood glucose continuous monitoring system An assembly of devices intended to be operated by a healthcare professional to continually measure patient blood glucose at the point of care in a healthcare facility. It is continuously connected to the patient during use and typically consists of a line-powered control unit, with user interface and rechargeable battery, containing a spectrometer to quantitatively measure glucose concentration in received plasma samples; a sterile, single-use cartridge connected to the patient via a venous catheter designed to withdraw a blood sample at intervals, convert it to plasma, and transport it to the control unit for analysis; a heparin syringe; and a sterile cap to protect the patient connector.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Do not expose to direct sunlight Special Storage Condition, Specify 0 0 Do not expose to rain or water Storage Environment Temperature 5 Degrees Celsius 35 Degrees Celsius
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 939218384 Device count 1 Lot or batch true Expiration date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850003892504 OptiScanner 5000 Glucose Monitoring System 5000 OPTI-5 2018-12-31
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850003892504 OptiScanner 5000 Glucose Monitoring System OPTISCAN BIOMEDICAL CORPORATION LZF 2018-12-31 00850003892504 OptiScanner 5000 Glucose Monitoring System OPTISCAN BIOMEDICAL CORPORATION PYV 2018-12-31
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