FDA.reportPublic FDA data

ABL77 CAPILLARY ADAPTERS

Primary DI
55700699060223
Brand
ABL77 CAPILLARY ADAPTERS
Company
Radiometer Medical ApS
Model
906-022
Catalog number
906-022
Device description
Capillary adaptor vented, 100 pcs. for ABL77
Published
2022-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GIOTUBE, COLLECTION, CAPILLARY BLOOD

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIOTube, Collection, Capillary BloodHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700699060228PrimaryGS10
55700699060223Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700699060228057006990602285700699060228
5570069906022355700699060223

GMDN Terms#

Term, Definition table
TermDefinition
Metabolic profile clinical chemistry analyser IVDA portable, electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemistry analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters (e.g., pO2, pCO2), electrolytes [e.g., Sodium (Na2+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine and sometimes in addition haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)].

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4538273827radiometer@radiometer.dk

Regulatory Flags#

DUNS number
308667539
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
05700699440211Calibration Solution944-021944-0212016-09-01
05700699441263Cleaning Solution with additive S8375 REF 944-126944-126944-1262018-09-21

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