FDA.reportPublic FDA data

S4970 Rinse 1 Solution for 600mL, for ABL7xx

Primary DI
05700699440570
Brand
S4970 Rinse 1 Solution for 600mL, for ABL7xx
Company
Radiometer Medical ApS
Model
944-057
Catalog number
944-057
Device description
Rinse Solution S4970 REF 944-057 600mL
Published
2018-09-21
Public version status
New
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
05700699440570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700699440570057006994405705700699440570

GMDN Terms#

Term, Definition table
TermDefinition
Wash/cleaning solution IVD, automated/semi-automated systemA concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius32 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+45999999999radiometer@radiometer.dk

Regulatory Flags#

DUNS number
308667539
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05700699456052Electrode for ABL analyzers945-605945-6052016-09-01
05700699565259PICO70956-525956-5252016-09-01
05700699565334PICO70956-533956-5332016-09-01
05700699565471PICO70956-547956-5472016-09-01
05700699566089safePICO70956-608956-6082016-09-01
05700699566096safePICO70956-609956-6092016-09-01
05700699566126safePICO70956-612956-6122016-09-01
05700699566133safePICO70956-613956-6132016-09-01
05700699566140safePICO70956-614956-6142016-09-01
05700699566157safePICO70956-615956-6152016-09-01
05700699566164safePICO70956-616956-6162016-09-01
05700699566232safePICO956-623956-6232016-09-01
05700699566249safePICO70956-624956-6242016-09-01
05700699056894TC contact liquid905-689905-6892016-09-01
05700693930978ABL90 FLEX393-097393-0972026-07-09
05700693930985ABL90 FLEX PLUS393-098393-0982026-07-09
05700699446572SP90944-657944-6572026-07-09
05700699447579SP90944-757944-7572026-07-09
05700699461056SC90946-105946-1052026-07-09
05700699461087SC90946-108946-1082026-07-09

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04719869706904Tyson Bio AC500 PRO Blood Glucose Monitoring System (Meter Only) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706911TysonBio AC500 PRO Blood Glucose Test Strips (50T)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706959Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
05700693930978ABL90 FLEXRadiometer Medical ApSCGZ2026-07-09
05700693930978ABL90 FLEXRadiometer Medical ApSCGA2026-07-09
05700693930978ABL90 FLEXRadiometer Medical ApSJGS2026-07-09
05700693930978ABL90 FLEXRadiometer Medical ApSJFP2026-07-09
05700693930978ABL90 FLEXRadiometer Medical ApSCHL2026-07-09
05700693930978ABL90 FLEXRadiometer Medical ApSKHP2026-07-09
05700693930978ABL90 FLEXRadiometer Medical ApSCEM2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSJFP2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCEM2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCGA2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCHL2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSKHP2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCGZ2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSJGS2026-07-09
05700699446572SP90Radiometer Medical ApSJGS2026-07-09
05700699446572SP90Radiometer Medical ApSJFP2026-07-09
05700699446572SP90Radiometer Medical ApSKHP2026-07-09
05700699446572SP90Radiometer Medical ApSCGZ2026-07-09
05700699446572SP90Radiometer Medical ApSCGA2026-07-09
05700699446572SP90Radiometer Medical ApSCEM2026-07-09
05700699446572SP90Radiometer Medical ApSCHL2026-07-09
05700699447579SP90Radiometer Medical ApSJGS2026-07-09
05700699447579SP90Radiometer Medical ApSCEM2026-07-09