StatStrip/StatSensor 50436

GUDID 00385480504362

Statstrip StatSensor Replacement Battery, 5 pack

NOVA BIOMEDICAL CORPORATION

Glucose monitoring system IVD, point-of-care
Primary Device ID00385480504362
NIH Device Record Key1846a72e-cafd-416d-be95-3d404ee19256
Commercial Distribution StatusIn Commercial Distribution
Brand NameStatStrip/StatSensor
Version Model Number1.0
Catalog Number50436
Company DUNS070617139
Company NameNOVA BIOMEDICAL CORPORATION
Device Count5
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 Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
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
GS100385480504362 [Primary]
GS100385489504363 [Unit of Use]

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 Number3
Public Version Date2019-08-09
Device Publish Date2016-09-20

Devices Manufactured by NOVA BIOMEDICAL CORPORATION

00385480636858 - StatStrip2024-04-05 StatStrip Glucose Hospital Meter System
20385480534936 - NOVA2023-08-03 NOVA MAX PLUS KETONE TEST STRIPS
00385480631648 - Nova Primary2023-03-06 Nova Primary Ampuled Control 1, 2
00385480631655 - Nova Primary2023-03-06 Nova Primary Linearity Level 1
00385480631662 - Nova Primary 2023-03-06 Nova Primary Linearity Level 2
00385480632300 - Nova Primary2023-03-02 Nova Primary Glucose Membrane
00385480631679 - Nova Primary2023-02-17 Nova Primary Calibrator Cartridge 150 Sample
00385480632317 - Nova Primary2023-02-17 Nova Primary Glucose Sensor

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