TCM4 combi module, TCpO2/O2 combi module 902-778

GUDID 05700699027788

TCM4 combi module, TCpO2/O2 combi module

Radiometer Medical ApS

Transcutaneous blood gas monitoring system
Primary Device ID05700699027788
NIH Device Record Keyc7afaefc-832c-4bdf-abc0-a725fa62b010
Commercial Distribution StatusIn Commercial Distribution
Brand NameTCM4 combi module, TCpO2/O2 combi module
Version Model Number902-778
Catalog Number902-778
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 Numbertrue
Manufacturing Datefalse
Expiration Datefalse
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
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk
Phone+459999999999
Emailradiometer@radiometer.dk

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS105700699027788 [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

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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