OptiScanner 5000 Glucose Monitoring System

FDA UDI

Class II (US FDA UDI)

by Optiscan Biomedical Corporation

Identity

Trade Name: OptiScanner 5000 Glucose Monitoring System FDA UDI
Generic Name: Point-of-care blood glucose monitoring system FDA UDI
Device Name: Automated, in-line, bedside, glucose monitoring system FDA UDI
Model / Reference: 5000 FDA UDI
Description: Automated, in-line, bedside, glucose monitoring system FDA UDI

Identifiers

Catalog Number: OPTI-5 FDA UDI
Primary DI / UDI-DI: 00850003892504 FDA UDI
510(k) Number: K162042 FDA UDI
FDA Product Code: PYV FDA UDI
LZF FDA UDI
GMDN Term: Point-of-care blood glucose monitoring system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1345 FDA UDI
880.5725 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Point-of-care blood glucose monitoring system

OptiScanner 5000 Glucose Monitoring System by Optiscan Biomedical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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OptiScanner 5000 Disposable Cartridge — OPTISCAN BIOMEDICAL CORPORATION · Class II

Cleared under the same submission

K162042 also covers:

OptiScanner 5000 Disposable Cartridge — OPTISCAN BIOMEDICAL CORPORATION

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Optiscan Biomedical Corporation

Sources (1)

FDA UDI 85903bd2-c994-4db1-8f6c-a2d72f7da1d0 36 fields · synced May 30, 2026