FDA.reportPublic FDA data

Calibration Solution

Primary DI
05700699440211
Brand
Calibration Solution
Company
Radiometer Medical ApS
Model
944-021
Catalog number
944-021
Device description
S7770 tHb calibration Solution (box of 4 ampoules), for ABL7XX/8XX
Published
2016-09-01
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
CIGDIAZO COLORIMETRY, BILIRUBIN
GKFINSTRUMENT, HEMATOCRIT, AUTOMATED
JFPELECTRODE, ION SPECIFIC, CALCIUM
JGSELECTRODE, ION SPECIFIC, SODIUM
JJSCONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)
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
CIGDiazo Colorimetry, BilirubinClinical Chemistry2
GKFInstrument, Hematocrit, AutomatedHematology2
JFPElectrode, Ion Specific, CalciumClinical Chemistry2
JGSElectrode, Ion Specific, SodiumClinical Chemistry2
JJSControls For Blood-Gases, (Assayed And Unassayed)Clinical Chemistry1
KHPAcid, Lactic, Enzymatic MethodClinical Chemistry1
MQMBilirubin (Total And Unbound) In The Neonate Test SystemClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700699440211PrimaryGS10
55700699440216Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700699440211057006994402115700699440211
5570069944021655700699440216

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood gas analyte IVD, calibratorA material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple blood gas analytes in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+459999999999radiometer@radiometer.dk

Regulatory Flags#

DUNS number
308667539
Device count
4
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05700699428929SAFE CLINIT. D957P-70-100X1942-892942-8922022-12-05
05700699428936SAFE CLINIT. D957P-70-125X1942-893942-8932022-12-05
05700699428981SAFE CLINITUBES D957P-70-70X1942-898942-8982024-07-01
05700699429698safeClinitubes D957P-70-45942-969942-9692022-12-05
05700699440174QUALICHECK 5+, LEVEL 1944-017944-0172022-12-05
05700699440198QUALICHECK 5+, LEVEL 3944-019944-0192022-12-05
05700699440822AUTOCHECK 3+, LEVEL 1, S7335944-082944-0822022-12-05
05700699440839AUTOCHECK 3+, LEVEL 2, S7345944-083944-0832022-12-05
05700699440846AUTOCHECK 3+, LEVEL 3, S7355944-084944-0842022-12-05
05700699440853AUTOCHECK 3+, LEVEL 4, S7365944-085944-0852022-12-05
05700699058027Disposable Waste Container D513 REF 905-802905-802905-8022018-09-21
05700699058713Membraning kit for tc sensor 84905-871905-8712016-09-01
05700699060266ABL90 FLEX, Clot catcher906-026906-0262016-09-01
05700699420589Membrane for E1001 electrode942-058942-0582016-09-01
05700699420633Membrane for E788 electrode942-063942-0632016-09-01
05700699420640Membrane for E799 electrode942-064942-0642016-09-01
05700699420664Membrane for E7077 electrode942-066942-0662016-09-01
05700699439062S5362 REF 943-906943-906943-9062018-09-21
05700699441263Cleaning Solution with additive S8375 REF 944-126944-126944-1262018-09-21
05700699441287Calibration Solution 1944-128944-1282016-09-01

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