FDA.reportPublic FDA data

Calibrant Fluid Pack

Primary DI
06944413803152
Brand
Calibrant Fluid Pack
Company
Edan Instruments, Inc.
Model
CP50
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
JIXCalibrator, Multi-Analyte Mixture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2

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
06944413802599PackageGS11In Commercial Distribution
06944413803145PackageGS16In Commercial Distribution
06944413803152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944413802599069444138025996944413802599
06944413803145069444138031456944413803145
06944413803152069444138031526944413803152

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibratorA material which is used to establish known points of reference for 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).

Regulatory Flags#

DUNS number
529173163
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
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

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