OptiScanner 5000 Glucose Monitoring System

Basic Information

• Brand Name: OptiScanner 5000 Glucose Monitoring System
• Primary DI: 00850003892504
• Version / Model: 5000
• Catalog Number: OPTI-5
• Company Name: OPTISCAN BIOMEDICAL CORPORATION
• Labeler DUNS: 939218384
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-31
• Public Version: 2
• Public Version Date: 2020-09-09
• Public Version Status: Update
• Public Device Record Key: 85903bd2-c994-4db1-8f6c-a2d72f7da1d0

Device Description

Automated, in-line, bedside, glucose monitoring system

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PYV	Hospital Continuous Glucose Monitoring System	Clinical Chemistry	862.1345	2
LZF	Pump, Infusion, Analytical Sampling	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58436	Point-of-care blood glucose 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850003892504	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K162042	000