HIGH METABOLITE QC, LEVEL 1 944-099

GUDID 55700699440995

S7570 QUALICHECK, level 1 High Metabolite - RED box of 30 ampoules. For ABL520/555, ABL7XX, EML105, NPT7

Radiometer Medical ApS

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Primary Device ID55700699440995
NIH Device Record Key3758cda3-c0ee-4e76-9b36-2ca643caf3f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameHIGH METABOLITE QC, LEVEL 1
Version Model Number944-099
Catalog Number944-099
Company DUNS308667539
Company NameRadiometer Medical ApS
Device Count30
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4538273827
Emailradiometer@radiometer.dk
Phone+4538273827
Emailradiometer@radiometer.dk
Phone+4538273827
Emailradiometer@radiometer.dk
Phone+4538273827
Emailradiometer@radiometer.dk
Phone+4538273827
Emailradiometer@radiometer.dk
Phone+4538273827
Emailradiometer@radiometer.dk
Phone+4538273827
Emailradiometer@radiometer.dk
Phone+4538273827
Emailradiometer@radiometer.dk
Phone+4538273827
Emailradiometer@radiometer.dk
Phone+4538273827
Emailradiometer@radiometer.dk
Phone+4538273827
Emailradiometer@radiometer.dk
Phone+4538273827
Emailradiometer@radiometer.dk
Phone+4538273827
Emailradiometer@radiometer.dk
Phone+4538273827
Emailradiometer@radiometer.dk
Phone+4538273827
Emailradiometer@radiometer.dk

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Biological risks. Do not reuse. Caution. Warning - May cause an allergic reaction.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Biological risks. Do not reuse. Caution. Warning - May cause an allergic reaction.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Biological risks. Do not reuse. Caution. Warning - May cause an allergic reaction.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Biological risks. Do not reuse. Caution. Warning - May cause an allergic reaction.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Biological risks. Do not reuse. Caution. Warning - May cause an allergic reaction.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Biological risks. Do not reuse. Caution. Warning - May cause an allergic reaction.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Biological risks. Do not reuse. Caution. Warning - May cause an allergic reaction.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Biological risks. Do not reuse. Caution. Warning - May cause an allergic reaction.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Biological risks. Do not reuse. Caution. Warning - May cause an allergic reaction.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Biological risks. Do not reuse. Caution. Warning - May cause an allergic reaction.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Biological risks. Do not reuse. Caution. Warning - May cause an allergic reaction.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Biological risks. Do not reuse. Caution. Warning - May cause an allergic reaction.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Biological risks. Do not reuse. Caution. Warning - May cause an allergic reaction.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Biological risks. Do not reuse. Caution. Warning - May cause an allergic reaction.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Biological risks. Do not reuse. Caution. Warning - May cause an allergic reaction.
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105700699440990 [Primary]
GS155700699440995 [Unit of Use]

FDA Product Code

JJSControls for blood-gases, (assayed and unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-13
Device Publish Date2022-12-05

Devices Manufactured by Radiometer Medical ApS

55700699428986 - SAFE CLINITUBES D957P-70-70X12024-07-09 D957P-70-70x1 safeCLINITUBES Blood Sampler Multipack with heparinized plastic capillaries and accessories. 70 µL, 1 vial of 250
05700699460509 - SC90 50 BG, LYT, MET, OXI + QC2024-07-09 SC90 50 BG, LYT, MET, OXI + QC
55700699428764 - CLINITUBES D941G-NA-240-85X102023-04-20 D941G-NA-240-85x10 CLINITUBES 10 vials of 75 units, Multipack
55700699044391 - CAPILLARY CAPS, RED 160pcs.2022-12-13 Capillary Caps, Red bag of 160 units
55700699044537 - CAPILLARY CAPS, green 110pcs.2022-12-13 Capillary Caps, Green bag of 110 units
55700699056615 - CLINITUBES D956G-70-35*12022-12-13 D956G-70-35x1 CLINITUBES 1 vial of 75 units. 35 µL. Multipack w. accessories
55700699060223 - ABL77 CAPILLARY ADAPTERS2022-12-13 Capillary adaptor vented, 100 pcs. for ABL77
05700699339393 - AQURE NT Premium2022-12-13 AQURE NT Premium
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