FDA.reportPublic FDA data

AUTOCHECK 3+, LEVEL 1, S7335

Primary DI
05700699440822
Brand
AUTOCHECK 3+, LEVEL 1, S7335
Company
Radiometer Medical ApS
Model
944-082
Catalog number
944-082
Device description
S7335 AutoCheck 3+, level 1 RED box of 30 ampoules. For ABL7X0
Published
2022-12-05
Public version status
Update
Distribution status
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
JJSControls for blood-gases, (assayed and unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJSControls For Blood-Gases, (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05700699440822PrimaryGS10
55700699440827Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700699440822057006994408225700699440822
5570069944082755700699440827

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood gas/haemoximetry/electrolyte analyte IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. 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
Special Storage Condition, Specify00Keep away from light.
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
308667539
Device count
30
Premarket exempt
true
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
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
05700699441287Calibration Solution 1944-128944-1282016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08718734963035CueSee® HyperbaricEurotrol B.V.JJS2026-01-07
08718734963042CueSee® HyperbaricEurotrol B.V.JJS2026-01-07
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10852676007121Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007138Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007145Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007152Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007169Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007176Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007183Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007190Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007206Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007213Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
10852676007114Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007124Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007131Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007148Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007155Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007162Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007179Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007186Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007193Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007209Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00852676007216Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJS2023-08-09
00811403014743Mission Control, Level 1Diamond Diagnostics Inc.JJS2023-06-05
00811403014750Mission Control, Level 2Diamond Diagnostics Inc.JJS2023-06-05
00811403014767Mission Control, Level 3Diamond Diagnostics Inc.JJS2023-06-05
00811403014781Mission Control, Level 1-2-3Diamond Diagnostics Inc.JJS2023-06-05
05700699252142QC AdaptorRadiometer Medical ApSJJS2022-12-08
05700699440174QUALICHECK 5+, LEVEL 1Radiometer Medical ApSJJS2022-12-05