STAT PROFILE 48584

GUDID 00385480485845

Stat Profile pHOx Ultra/CCX Replacement Gasket Kit Flow- Through Sensor

NOVA BIOMEDICAL CORPORATION

Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Primary Device ID00385480485845
NIH Device Record Key54583097-1242-4666-bd08-60c6447459f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTAT PROFILE
Version Model NumberPHOX ULTRA/CCX
Catalog Number48584
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 Batchtrue
Serial Numberfalse
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

Operating and Storage Conditions

Storage 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
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100385480485845 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BXXCALIBRATOR, PRESSURE, GAS

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 [STAT PROFILE]

10385480616154Stat Profile Prime Plus MicroSensor Card™ with COOX
10385480616147Stat Profile Prime Plus MicroSensor Card™ with COOX (High Volume)
10385480595084Stat Profile Prime Plus® Analyzer (Remanufactured)
10385480586433Stat Profile Prime Plus MicroSensor Card™ (High Volume)
10385480586426Stat Profile Prime Plus MicroSensor Card™
10385480583791Stat Profile Prime Plus MicroSensor Card™ BLANK
00385480578455Stat Profile Prime Plus Ampuled Controls Chemistry Levels 4,5
00385480578448Stat Profile Prime Plus Ampuled Controls BG, COOX Levels 1, 2, 3
00385480578431Stat Profile Prime Plus Auto QC Cartridge 315 Sample with Creat / BUN
00385480578424Stat Profile Prime Plus Auto QC Cartridge 210 Sample with Creat / BUN
00385480578417Stat Profile Prime Plus Auto QC Cartridge 105 Sample with Creat / BUN
00385480578400Stat Profile Prime Plus Auto QC Cartridge 480 Sample
00385480578394Stat Profile Prime Plus Auto QC Cartridge 320 Sample
00385480578387Stat Profile Prime Plus Auto QC Cartridge 160 Sample
00385480578356Stat Profile Prime Plus Calibrator Cartridge 500 Sample with Creat / BUN
00385480578349Stat Profile Prime Plus Calibrator Cartridge 400 Sample with Creat / BUN
00385480578332Stat Profile Prime Plus Calibrator Cartridge 300 Sample with Creat / BUN
00385480578325Stat Profile Prime Plus Calibrator Cartridge 200 Sample with Creat / BUN
00385480578318Stat Profile Prime Plus Calibrator Cartridge 100 Sample with Creat / BUN
00385480578295Stat Profile Prime Plus Calibrator Cartridge 500 Sample
00385480578288Stat Profile Prime Plus Calibrator Cartridge 400 Sample
00385480578271Stat Profile Prime Plus Calibrator Cartridge 300 Sample
00385480578264Stat Profile Prime Plus Calibrator Cartridge 200 Sample
00385480578257Stat Profile Prime Plus Calibrator Cartridge 100 Sample
00385480578233Stat Profile Prime Plus Reference Cartridge
10385480578216Stat Profile Prime Plus MicroSensor Card™ BUN, Creatinine
10385480574003Stat Profile Prime Plus® Analyzer
00385480567268Prime Capillary Tube 150 uL with Balanced Heparin 250 per vial
00385480567251Prime Capillary Tube 230 uL with Balanced Heparin 250 per vial
00385480561983Linearity Standard Set G Multipack
10385480552643Prime Sensor Card CCS Comp (High Volume)
10385480552636Prime Sensor Card CCS (High Volume)
10385480552629Prime Sensor Card ABG (High Volume)
00385480536677Remanufactured Prime CCS Comp w/ Scanner Analyzer
00385480536660Remanufactured Prime CCS w/ Scanner Analyzer
00385480536653Remanufactured Prime ABG w/ Scanner Analyzer
00385480536578Prime CCS Comp w/ Scanner Analyzer
00385480536561Prime CCS w/ Scanner Analyzer
00385480536554Prime ABG w/ Scanner Analyzer
10385480534694Prime Calibrator Cartridge CCS Comp 500 Sample
00385480534673Prime Calibrator Cartridge CCS 500 Sample
00385480534666Prime Calibrator Cartridge CCS 400 Sample
00385480534642Prime Calibrator Cartridge ABG 500 Sample
00385480534635Prime Calibrator Cartridge ABG 400 Sample
00385480534567Prime Auto QC Cartridge ABG 100 Sample
00385480534550Prime Auto QC Cartridge CCS 100 Sample
00385480534215Remanufactured PRIME ABG Analyzer
00385480534208Remanufactured PRIME CCS Comp Analyzer
00385480534185Remanufacture PRIME CCS Analyzer
00385480533652Prime Calibrator Cartridge CCS Comp 200 Sample

Trademark Results [STAT PROFILE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STAT PROFILE
STAT PROFILE
85532383 4420520 Live/Registered
Nova Biomedical Corporation
2012-02-02
STAT PROFILE
STAT PROFILE
73634700 1453109 Dead/Cancelled
NOVA BIOMEDICAL CORPORATION
1986-12-11

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