FDA.reportPublic FDA data

D155 - REF 905-248 Disposable Waste Container

Primary DI
05700699052483
Brand
D155 - REF 905-248 Disposable Waste Container
Company
Radiometer Medical ApS
Model
905-248
Catalog number
905-248
Device description
D155 - REF 905-248 Disposable Waste Container for ABL5
Published
2018-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
05700699052483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700699052483057006990524835700699052483

GMDN Terms#

Term, Definition table
TermDefinition
Metabolic profile clinical chemistry analyser IVD, stationary, automatedA stationary mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemisty analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters [e.g., partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2)], electrolytes [e.g., sodium (Na2+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine and sometimes haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)]. The device operates with minimal technician involvement and complete automation of all procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Warning biological hazard Single use

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
308667539
Device count
1

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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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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