StatSensor/StatStrip 53402

GUDID 10385480534021

StatStrip StatSensor Docking Station

NOVA BIOMEDICAL CORPORATION

Glucose monitoring system IVD, point-of-care
Primary Device ID10385480534021
NIH Device Record Keyda8bc3a7-eda3-48f3-a46d-5b8c381ba8e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameStatSensor/StatStrip
Version Model Number1.75
Catalog Number53402
Company DUNS070617139
Company NameNOVA BIOMEDICAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)545-6682
Emailinfo@novabio.com
Phone+1(800)545-6682
Emailinfo@novabio.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100385480534024 [Primary]
GS110385480534021 [Package]
Contains: 00385480534024
Package: carton [1 Units]
In Commercial Distribution

FDA Product Code

CGAGLUCOSE OXIDASE, GLUCOSE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-08-09
Device Publish Date2016-09-20

On-Brand Devices [StatSensor/StatStrip]

10385480560372StatStrip Docking Station Remanufactured 4 position 1.75
10385480560365StatStrip Docking Station Remanufactured 2 position 1.75
10385480544228StatStrip StatSensor Remanufactured Wireless Carrying Case for Meter and Supplies v1.0
10385480544198StatStrip StatSensor Remanufactured Wireless Carrying Case for Meter and Supplies
10385480534397StatStrip StatSensor Wireless Carrying Case for Meter and Supplies
10385480534021StatStrip StatSensor Docking Station
10385480534014StatStrip StatSensor Docking Station
10385480534007StatStrip StatSensor Docking Station
10385480519967Statsensor Statstrip Docking Station 4 position
10385480519950Statsensor Statstrip Docking Station 2 position
10385480519943Statsensor Statstrip Docking Station
10385480517567StatSensor StatStrip Docking Station Remanufactured
10385480486306StatSensor StatStrip Wireless Carrying Case for Meter and Supplies
10385480486290StatSensor StatStrip Docking Station for Wireless Carrying Case
10385480438060StatSensor Stat Strip Docking Station Non Network Capable
10385480422250StatSensor StatStrip Docking Station

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