FDA.reportPublic FDA data

Avoximeter Whole Blood CO-Oximeter

Primary DI
10711234160039
Brand
Avoximeter Whole Blood CO-Oximeter
Company
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
Model
4-QCYO
Catalog number
4-QCYO
Device description
Avoximeter Whole Blood CO-Oximeter Optical QC Filters
Published
2016-09-22
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
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
10711234160039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1071123416003910711234160039

GMDN Terms#

Term, Definition table
TermDefinition
Co-oximetry analyser IVD, point-of-careA mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care, and often in the laboratory, for the quantitative in vitro measurement of oxygen saturation, haemoglobin derivatives and other calculated haemoximetry parameters in a whole blood specimen. Measurements may include haemoglobin oxygen saturation (SpO2), arterial oxygen saturation (SaO2), blood oxygen content/capacity, and haemoglobin forms such as oxyhaemoglobin (O2Hb), deoxyhaemoglobin (HHb) or reduced haemoglobin (RHb), carboxy-haemoglobin (COHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb), and total haemoglobin (totHb).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079299318
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10711234170342directCHECK ACT+ Whole Blood Control Level 1000DCGACT-1000DCGACT-12022-01-21
10711234170359directCHECK ACT+ Whole Blood Control, Level 2000DCGACT-2000DCGACT-22022-01-21
10711234170366directCHECK ACT-LR Whole Blood Controls, Level 1000DCGLR-1000DCGLR-12022-01-21
10711234170373directCHECK ACT-LR Whole Blood Control, Level 2000DCGLR-2000DCGLR-22022-01-21
10711234101230Hemochron Whole Blood Coagulation SystemPDAOPDAO2016-09-22
10711234102176Hemochron Whole Blood Coagulation SystemRQCHRTRQCHRT2016-09-22
10711234102183Hemochron Whole Blood Coagulation SystemRQCPRTRQCPRT2016-09-22
10711234102206Hemochron Whole Blood Coagulation SystemQCACTQCACT2016-09-22
10711234107027directCHECK Whole Blood ControlsDCJAPTT-NDCJAPTT-N2016-09-22
10711234107034directCHECK Whole Blood ControlsDCJAPTT-ADCJAPTT-A2016-09-22
10711234107041directCHECK Whole Blood ControlsDCJPT-ADCJPT-A2016-09-22
10711234107058directCHECK Whole Blood ControlsDCJACT-ADCJACT-A2016-09-22
10711234107065directCHECK Whole Blood ControlsDCJCPT-ADCJCPT-A2016-09-22
10711234107072directCHECK Whole Blood ControlsDCJCPT-NDCJCPT-N2016-09-22
10711234107089directCHECK Whole Blood ControlsDCJLR-ADCJLR-A2016-09-22
10711234107096HepCheck Whole Blood ControlDCP214-NDCP214-N2016-09-22
10711234107102HepCheck Whole Blood ControlDCP214-ADCP214-A2016-09-22
10711234170175directCHECK Whole Blood ControlsDCJCAPTT-ADCJCAPTT-A2016-09-22
10711234170229directCHECK Whole Blood ControlsDCJACT-NDCJACT-N2016-09-22
10711234170236directCHECK Whole Blood ControlsDCJPT-NDCJPT-N2016-09-22

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
08426950452577GEM OPL (110V)INSTRUMENTATION LABORATORY COMPANYJKS2016-09-23
08426950452614TEMPERATURE PROBEINSTRUMENTATION LABORATORY COMPANYJKS2016-09-23
08426950813590OPTICAL QC FILTERSINSTRUMENTATION LABORATORY COMPANYJKS2016-09-23
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