OptiScanner 5000 Glucose Monitoring System OPTI-5

GUDID 00850003892504

Point-of-care blood glucose continuous monitoring system

Primary Device ID	00850003892504
NIH Device Record Key	85903bd2-c994-4db1-8f6c-a2d72f7da1d0
Commercial Distribution Status	In Commercial Distribution
Brand Name	OptiScanner 5000 Glucose Monitoring System
Version Model Number	5000
Catalog Number	OPTI-5
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	false
Lot Batch	false
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

Device Issuing Agency	Device ID
GS1	00850003892504 [Primary]

PYV	Hospital Continuous Glucose Monitoring System

Steralize Prior To Use	false
Device Is Sterile	false

00850003892054 - OptiScanner 5000 Disposable Cartridge	2019-01-31 OptiScanner Disposable Cartridge
00850003892504 - OptiScanner 5000 Glucose Monitoring System	2019-01-31Automated, in-line, bedside, glucose monitoring system
00850003892504 - OptiScanner 5000 Glucose Monitoring System	2019-01-31 Automated, in-line, bedside, glucose monitoring system