DEVICE: Calibration Gas (05700699621887)

Device Identifier (DI) Information

Calibration Gas
962-188
In Commercial Distribution
962-188
Radiometer Medical ApS
05700699621887
GS1

1
308667539 *Terms of Use
TCM4 CAL GAS
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Transcutaneous blood gas monitor, paediatric A mains electricity (AC-powered) device designed for the continuous, transcutaneous (through the skin) measure of the partial pressure of oxygen (pO2) and the partial pressure of carbon dioxide (pCO2) in a paediatric patient's blood. It includes a special sensor that is typically heated to increase the blood flow and gas diffusion at the point of application on the skin's surface. The gas then diffuses through the membrane of the sensor and is measured by the device; results are digitally displayed and/or printed. This device is especially used to measure and display pO2/pCO2 in infants not under gas anaesthesia.
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FDA Product Code

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Product Code Product Code Name
LKD MONITOR, CARBON-DIOXIDE, CUTANEOUS
LPP Monitor, oxygen, cutaneous, for uses other than for infant not under gas anesthesia
DPZ Oximeter, ear
KLK Monitor, oxygen, cutaneous, for infant not under gas anesthesia
DQA Oximeter
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use.
Storage Environment Temperature: between 4 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

670c3ab9-1ce8-4e1d-962d-a574434ad9bf
March 29, 2018
2
September 01, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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+459999999999
radiometer@radiometer.dk
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