Calibration Gas 962-188

GUDID 05700699621887

TCM4 CAL GAS

Radiometer Medical ApS

Transcutaneous blood gas monitor, paediatric Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder Calibration gas/non-refillable cylinder
Primary Device ID05700699621887
NIH Device Record Key670c3ab9-1ce8-4e1d-962d-a574434ad9bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameCalibration Gas
Version Model Number962-188
Catalog Number962-188
Company DUNS308667539
Company NameRadiometer Medical ApS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use.
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use.
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use.
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use.
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use.
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use.
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use.
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use.
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use.
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use.
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use.
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use.
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use.
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use.
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105700699621887 [Primary]

FDA Product Code

LKDMONITOR, CARBON-DIOXIDE, CUTANEOUS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-01

Devices Manufactured by Radiometer Medical ApS

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
05700699339409 - AQURE NT Plus2022-12-13 AQURE NT Plus
55700699428696 - CLINITUBES D957G-70-35X52022-12-13 D957G-70-35x5 CLINITUBES 5 vials of 75 units. 35 µL. Multipack w. accessories

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