OptiScanner 5000 Disposable Cartridge

FDA UDI

Class II (US FDA UDI)

by Optiscan Biomedical Corporation

Identity

Trade Name: OptiScanner 5000 Disposable Cartridge FDA UDI
Generic Name: Point-of-care blood glucose monitoring system FDA UDI
Device Name: OptiScanner Disposable Cartridge FDA UDI
Model / Reference: 5000 FDA UDI
Description: OptiScanner Disposable Cartridge FDA UDI

Identifiers

Primary DI / UDI-DI: 00850003892054 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Point-of-care blood glucose monitoring system

OptiScanner 5000 Disposable Cartridge by Optiscan Biomedical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Accu-Chek Inform II Instrument with RF card — Roche Diagnostics Corp. · Class II
OptiScanner 5000 Glucose Monitoring System — OPTISCAN BIOMEDICAL CORPORATION · Class II

Cleared under the same submission

K162042 also covers:

OptiScanner 5000 Glucose Monitoring System — 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 7179050a-2c2e-4d0a-814c-4fc71f242993 36 fields · synced May 29, 2026