FDA.reportPublic FDA data

AUTOCHECK 3+, LEVEL 2, S7345

Primary DI
05700699440839
Brand
AUTOCHECK 3+, LEVEL 2, S7345
Company
Radiometer Medical ApS
Model
944-083
Catalog number
944-083
Device description
S7345 AutoCheck 3+, level 2 YELLOW 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
05700699440839PrimaryGS10
55700699440834Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700699440839057006994408395700699440839
5570069944083455700699440834

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
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
05700699461094SC90946-109946-1092026-07-09
05700699461100SC90946-110946-1102026-07-09
05700699461131SC90946-113946-1132026-07-09
05700699461605SC90946-160946-1602026-07-09
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
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

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
00380740153694AlinityABBOTT LABORATORIESJJS2023-10-14
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