Stat Profile 62636

GUDID 10385480626368

Remanufactured Prime ES Plus w/ Tray

NOVA BIOMEDICAL CORPORATION

Multichannel clinical chemistry analyser IVD, point-of-care, line-powered
Primary Device ID10385480626368
NIH Device Record Keyc673fafc-4266-48aa-b258-0520c50b6510
Commercial Distribution StatusIn Commercial Distribution
Brand NameStat Profile
Version Model NumberPrime ES Plus
Catalog Number62636
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 Datefalse
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
Email[email protected]

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100385480626361 [Primary]
GS110385480626368 [Package]
Contains: 00385480626361
Package: Box [1 Units]
In Commercial Distribution

FDA Product Code

CHLElectrode measurement, blood-gases (pco2, po2) and blood ph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-11
Device Publish Date2020-02-03

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

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.