FDA.reportPublic FDA data

GEM OPL (110V)

Primary DI
08426950452577
Brand
GEM OPL (110V)
Company
INSTRUMENTATION LABORATORY COMPANY
Model
06320480000
Catalog number
06320480000
Device description
GEM OPL (110V)
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JKSSpectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKSSpectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-MonoxideClinical Toxicology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951485000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951485000AVOXIMETER 4000A-Vox Systems, Inc.1995-11-06JKS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08426950452577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08426950452577084269504525778426950452577

GMDN Terms#

Term, Definition table
TermDefinition
Blood gas/haemoximetry analyser IVD, laboratory, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the quantitative in vitro measurement of blood pH, partial pressure of oxygen (pO2) and/or partial pressure of carbon dioxide (pCO2), and the measurement or calculation of other blood gas and co-oximetry parameters [e.g., bicarbonate (HCO3-), base excess, arterial-alveolar gradient, oxyhaemoglobin (O2Hb), deoxyhaemoglobin (HHb) or reduced haemoglobin (RHb), carboxy-haemoglobin (COHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb), and total haemoglobin (totHb)] in a clinical specimen. The device operates with minimal technician involvement and complete automation of all procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
Serial number
true
Manufacturing 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
00385480097987STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2017-12-19
10711234530245Avoximeter Whole Blood CO-OximeterACCRIVA DIAGNOSTICS HOLDINGS, INC.JKS2017-02-10
10711234530252Avoximeter Whole Blood CO-OximeterACCRIVA DIAGNOSTICS HOLDINGS, INC.JKS2017-02-10
10711234530276Avoximeter Whole Blood CO-OximeterACCRIVA DIAGNOSTICS HOLDINGS, INC.JKS2017-02-10
08426950490791GEM OPL (220V)INSTRUMENTATION LABORATORY COMPANYJKS2016-09-23
08426950088684GEM OPL CUVETTESINSTRUMENTATION LABORATORY COMPANYJKS2016-09-23
08426950452614TEMPERATURE PROBEINSTRUMENTATION LABORATORY COMPANYJKS2016-09-23
08426950813590OPTICAL QC FILTERSINSTRUMENTATION LABORATORY COMPANYJKS2016-09-23
10711234160039Avoximeter Whole Blood CO-OximeterACCRIVA DIAGNOSTICS HOLDINGS, INC.JKS2016-09-22
10711234160046Avoximeter Whole Blood CO-OximeterACCRIVA DIAGNOSTICS HOLDINGS, INC.JKS2016-09-22
10711234160053Avoximeter Whole Blood CO-OximeterACCRIVA DIAGNOSTICS HOLDINGS, INC.JKS2016-09-22
10711234530054Avoximeter Whole Blood CO-OximeterACCRIVA DIAGNOSTICS HOLDINGS, INC.JKS2016-09-22
00385480118026STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-22
00385480214902STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480239622STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480340816STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480347174STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480355360STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480359429STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480374132STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480375559STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480375627STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480380256STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480214971STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480215121STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480215138STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480215190STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480215206STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480225076STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20
00385480230230STAT PROFILENOVA BIOMEDICAL CORPORATIONJKS2016-09-20