NOVA MAX 49640

GUDID 00385480496407

Nova Max Plus Glu/Ket Control Solution - Mid

NOVA BIOMEDICAL CORPORATION

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Primary Device ID00385480496407
NIH Device Record Key7b03d5f9-9688-4e45-8237-37083e441b44
Commercial Distribution StatusIn Commercial Distribution
Brand NameNOVA MAX
Version Model NumberPlus
Catalog Number49640
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

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

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100385480496407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJYMulti-analyte controls, all kinds (assayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-20

On-Brand Devices [NOVA MAX]

00385480496407Nova Max Plus Glu/Ket Control Solution - Mid
10385480458242Nova Max Plus Blood Glucose Monitoring System
10385480445853Nova Max Link with Battery and Quick Reference Guide
00385480434461Nova Max Glucose Normal Glucose Control Solution
10385480434369Nova Max Plus Blood Glucose Monitoring System
10385480434352Nova Max Plus Plus Blood Glucose Monitoring System

Trademark Results [NOVA MAX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NOVA MAX
NOVA MAX
77061335 3436977 Live/Registered
Nova Biomedical Corporation
2006-12-11

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