FDA.reportPublic FDA data

Hematocrit Control

Primary DI
06944413802018
Brand
Hematocrit Control
Company
Edan Instruments, Inc.
Model
High
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GLKControl, Hematocrit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GLKControl, HematocritHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151978000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151978000EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit ControlEdan Instruments, Inc.2016-07-15CHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944413802018PrimaryGS10
06944413807891Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944413802018069444138020186944413802018
06944413807891069444138078916944413807891

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood gas/haemoximetry/electrolyte analyte IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. 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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529173163
Device count
5
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
06944413817210Connection Cable01.57.4721782026-05-19
06944413817234 Connection Cable01.57.4722162026-05-19
06944413820050EMG/Stimulation sensor01.57.4726242026-05-19
06944413820074EMG/Stimulation sensor01.57.4726312026-05-19
06944413825475Connection Cable01.57.4722812026-05-19
06944413825482Connection Cable01.57.4723812026-05-19
06944413834026EMG/Stimulation sensor01.57.4726252026-05-19
06944413834736EMG/Stimulation sensor01.57.472623 2026-05-19
06944413866133Stimulation SystemPR362026-05-15
06944413866140Stimulation SystemPR382026-05-15
06944413866157Stimulation SystemPR4 Pro2026-05-15
06944413866164Stimulation SystemPR42026-05-15
06944413866171Stimulation SystemPA362026-05-15
06944413866188Stimulation SystemPA382026-05-15
06944413866195Stimulation SystemPA4 Pro2026-05-15
06944413866201Stimulation SystemPA42026-05-15
06944413866218Stimulation SystemQ32026-05-15
06944413866225Stimulation SystemQ92026-05-15
06944413866232Stimulation SystemQ102026-05-15
06944413866249Stimulation SystemQ122026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08426951293827ChemSTAT Hematocrit Evaluator 1INSTRUMENTATION LABORATORY COMPANYGLK2019-06-26
08426951293834ChemSTAT Hematocrit Evaluator 2INSTRUMENTATION LABORATORY COMPANYGLK2019-06-26
08426951293841ChemSTAT Hematocrit Evaluator 3INSTRUMENTATION LABORATORY COMPANYGLK2019-06-26
08426951293858GEM ChemSTAT critPVP 1-4INSTRUMENTATION LABORATORY COMPANYGLK2019-06-26
00831829000137HemataChek, Low, Normal, High ControlSEPARATION TECHNOLOGY, INC.GLK2017-08-25
00831829000144HemataChek, Low & Normal ControlSEPARATION TECHNOLOGY, INC.GLK2017-08-25
00831829000151HemataChek, Normal & High ControlSEPARATION TECHNOLOGY, INC.GLK2017-08-25
00831829000168HemataChek Low Control SEPARATION TECHNOLOGY, INC.GLK2017-08-25
00831829000182HemataChek Normal Control SEPARATION TECHNOLOGY, INC.GLK2017-08-25
00831829000205HemataChek High ControlSEPARATION TECHNOLOGY, INC.GLK2017-08-25
00630414121789RAPIDQC® Hct Level ASiemens Healthcare Diagnostics Inc.GLK2016-09-24
00630414121796RAPIDQC® Hct Level BSiemens Healthcare Diagnostics Inc.GLK2016-09-24
08426950452058GEM critCheckINSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950511526IL critPVPINSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950046653Hct Check - Low LevelINSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950046660Hct Check - High LevelINSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950446231GEM CVP (Calibration Valuation Product) 3 HematocritINSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950446248GEM CVP (Calibration Valuation Product) 4 HematocritINSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950573661GEM Hematocrit Evaluator 1INSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950573678GEM Hematocrit Evaluator 2INSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
08426950573685GEM Hematocrit Evaluator 3INSTRUMENTATION LABORATORY COMPANYGLK2016-09-23
06944413801875Blood Gas and Chemistry AnalyzerEdan Instruments, Inc.GLK2016-09-01
06944413802025Hematocrit ControlEdan Instruments, Inc.GLK2016-09-01
08718734960423EurotrolEurotrol B.V.GLK2016-08-26
08718734960430EurotrolEurotrol B.V.GLK2016-08-26
08718734960454EurotrolEurotrol B.V.GLK2016-08-26
08718734960478EurotrolEurotrol B.V.GLK2016-08-26