FDA.reportPublic FDA data

ABL77 Sci

Primary DI
05700699456526
Brand
ABL77 Sci
Company
Radiometer Medical ApS
Model
945-652
Catalog number
945-652
Device description
SCi50/30 days Full Sensor cassette, 50 tests, 30 days in use lifetime. BG, Hct and electrolytes, for ABL77
Published
2016-09-01
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
CHLELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700699456526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700699456526057006994565265700699456526

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologiesA collection of reagents and other associated materials intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample, using multiple technologies such as ion-selective electrode (ISE) and haemoximetry in a single analyser. 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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius32 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+459999999999radiometer@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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCHL2026-07-09
05700699446572SP90Radiometer Medical ApSCHL2026-07-09
05700699447579SP90Radiometer Medical ApSCHL2026-07-09
05700699461056SC90Radiometer Medical ApSCHL2026-07-09
05700699461087SC90Radiometer Medical ApSCHL2026-07-09
05700699461094SC90Radiometer Medical ApSCHL2026-07-09
05700699461100SC90Radiometer Medical ApSCHL2026-07-09
05700699461131SC90Radiometer Medical ApSCHL2026-07-09
05700699461605SC90Radiometer Medical ApSCHL2026-07-09
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