FDA.reportPublic FDA data

OptiScanner 5000 Glucose Monitoring System

Primary DI
00850003892504
Brand
OptiScanner 5000 Glucose Monitoring System
Company
OPTISCAN BIOMEDICAL CORPORATION
Model
5000
Catalog number
OPTI-5
Device description
Automated, in-line, bedside, glucose monitoring system
Published
2018-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZFPump, Infusion, Analytical Sampling
PYVHospital Continuous Glucose Monitoring System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZFPump, Infusion, Analytical SamplingGeneral Hospital2
PYVHospital Continuous Glucose Monitoring SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162042000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162042000OptiScanner 5000 Glucose Monitoring SystemOptiscan Biomedical Corp.2017-10-16LZF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850003892504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003892504008500038925048500038925040850003892504

GMDN Terms#

Term, Definition table
TermDefinition
Point-of-care blood glucose continuous monitoring systemAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
510.962.6207ccastillo@optiscancorp.com
510.342.5818edeperalta@optiscancorp.com

Regulatory Flags#

DUNS number
939218384
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850003892054OptiScanner 5000 Disposable Cartridge50002018-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850003892054OptiScanner 5000 Disposable CartridgeOPTISCAN BIOMEDICAL CORPORATIONLZF2018-12-31
00850003892054OptiScanner 5000 Disposable CartridgeOPTISCAN BIOMEDICAL CORPORATIONPYV2018-12-31