FDA.reportPublic FDA data

GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 75 TEST

Primary DI
08426950807643
Brand
GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 75 TEST
Company
INSTRUMENTATION LABORATORY COMPANY
Model
00055407511
Catalog number
00055407511
Device description
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 75 Test 31 Days
Published
2018-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CEMElectrode, Ion Specific, Potassium
CGAGlucose Oxidase, Glucose
CGZElectrode, Ion-Specific, Chloride
CHLELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
GHSAssay, Carboxyhemoglobin
GLYOximeter To Measure Hemoglobin
JFPElectrode, Ion Specific, Calcium
JGSElectrode, Ion Specific, Sodium
KHPAcid, Lactic, Enzymatic Method
MQMBilirubin (Total And Unbound) In The Neonate Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2
CGAGlucose Oxidase, GlucoseClinical Chemistry2
CGZElectrode, Ion-Specific, ChlorideClinical Chemistry2
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhClinical Chemistry2
GHSAssay, CarboxyhemoglobinHematology2
GLYOximeter To Measure HemoglobinHematology2
JFPElectrode, Ion Specific, CalciumClinical Chemistry2
JGSElectrode, Ion Specific, SodiumClinical Chemistry2
KHPAcid, Lactic, Enzymatic MethodClinical Chemistry1
MQMBilirubin (Total And Unbound) In The Neonate Test SystemClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160225000
K160402000
K160415000
K173403000
K203790000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160225000GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit EvaluatorInstrumentation Laboratory CO2016-12-14JGS
K160402000GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)Instrumentation Laboratory CO2016-12-14CGA
K160415000GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)Instrumentation Laboratory CO2016-12-14GKF
K173403000GEM Premier 5000Instrumentation Laboratory CO2017-12-29CHL
K203790000GEM Premier 5000Instrumentation Laboratory CO2021-08-20CHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950807643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950807643084269508076438426950807643

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologiesA collection of reagents and other associated materials intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample, using multiple technologies such as ion-selective electrode (ISE) and haemoximetry in a single analyser. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00STORE at 15-25 Degrees Celsius DO NOT FREEZE Do not open cartridge protective wrapper until ready to use.
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-678-0710techsupport@werfen.com
1-800-678-0710techsupport.na@werfen.com

Regulatory Flags#

DUNS number
557223252
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08426950071068HemosIL Normal Control ASSAYED00020003110000200031102016-09-23
08426950088646GEM Check Coag Control-Abnormal for ACT-LR06260060200062600602002016-09-23
08426950088653GEM Check Coag Control-Abnormal for ACT06260060300062600603002016-09-23
08426950452683GEM Check Coag Control-Normal for Citrate PT06260061100062600611002016-09-23
08426950452713GEM Check Coag Control-Abnormal for Citrate PT06260061400062600614002016-09-23
08426950452744GEM Check Coag Control-Normal for ACT06260060500062600605002016-09-23
08426950452751GEM Check Coag Control-Normal for ACT-LR06260060600062600606002016-09-23
08426950573401HemosIL Routine Control Level 300020005800000200058002016-09-23
08426950660668HemosIL Abnormal Control 200020014000000200140002016-09-23
08426950078982HemosIL Low Abnormal Control ASSAYED00020003210000200032102016-09-23
08426950078999HemosIL High Abnormal Control ASSAYED00020003310000200033102016-09-23
08426950087595HemosIL Calibration Plasma00020003700000200037002016-09-23
08426950088639GEM Check Coag Control-Abnormal for APTT06260060100062600601002016-09-23
08426950088912Coatest APCR Control Plasma Level 182 2650 6382 2650 632016-09-23
08426950088929Coatest APCR Control Plasma Level 282 2668 6382 2668 632016-09-23
08426950442189HemosIL Special Test Control Level 200020012000000200120002016-09-23
08426950452690GEM Check Coag Control-Normal for APTT06260061600062600616002016-09-23
08426950452706GEM Check Coag Control-Abnormal for PT06260061700062600617002016-09-23
08426950452737GEM Check Coag Control-Normal for PT06260060400062600604002016-09-23
08426950453062HemosIL Special Test Control Level 100020011000000200110002016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10054749005502i-STATABBOTT POINT OF CARE INC.CHL2020-10-05
10054749005502i-STATABBOTT POINT OF CARE INC.KHP2020-10-05
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdCGA2020-09-11
08809301160862Pip Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2020-09-11
10054749005519i-STATABBOTT POINT OF CARE INC.JFP2020-05-01
08809301160411Gmate Smart Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-09-17
08809301168011GlucoTrack Blood Glucose Test StripsPHILOSYS Co., LtdCGA2018-08-16
08809301168042GlucoTrack Blood Glucose Test StripsPHILOSYS Co., LtdCGA2018-08-16
08809301168080GlucoTrack Voice Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-08-16
08809301168097GlucoTrack VOICE Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-08-16
08809301168103GlucoTrack VOICE Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-08-16
08809301168110GlucoTrack SMART Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-08-16
08809301168127GlucoTrack SMART Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-08-16
08809301168134GlucoTrack SMART Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2018-08-16
08426950807544GEM Premier 5000 PAK BG/COOX/TBILI 75 TESTINSTRUMENTATION LABORATORY COMPANYGLY2018-01-24
08426950807544GEM Premier 5000 PAK BG/COOX/TBILI 75 TESTINSTRUMENTATION LABORATORY COMPANYMQM2018-01-24
08426950807544GEM Premier 5000 PAK BG/COOX/TBILI 75 TESTINSTRUMENTATION LABORATORY COMPANYGHS2018-01-24
08426950807568GEM Premier 5000 PAK BG/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYGLY2018-01-24
08426950807568GEM Premier 5000 PAK BG/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYGHS2018-01-24
08426950807568GEM Premier 5000 PAK BG/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYMQM2018-01-24
08426950807575GEM Premier 5000 PAK BG/ISE/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYCEM2018-01-24
08426950807575GEM Premier 5000 PAK BG/ISE/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYGHS2018-01-24
08426950807575GEM Premier 5000 PAK BG/ISE/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807575GEM Premier 5000 PAK BG/ISE/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYJGS2018-01-24
08426950807575GEM Premier 5000 PAK BG/ISE/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYGLY2018-01-24
08426950807575GEM Premier 5000 PAK BG/ISE/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYCGZ2018-01-24
08426950807582GEM Premier 5000 PAK BG/ISE/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYGHS2018-01-24
08426950807582GEM Premier 5000 PAK BG/ISE/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807582GEM Premier 5000 PAK BG/ISE/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYGLY2018-01-24
08426950807582GEM Premier 5000 PAK BG/ISE/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYCEM2018-01-24