DEVICE: Accessories starter kit for ABL800 FLEX (05700699058348)

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Device Identifier (DI) Information

Accessories starter kit for ABL800 FLEX
905-834
905-834
Radiometer Medical ApS
05700699058348
GS1
1
Accessories starter kit for ABL800 FLEX
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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 sensor A device intended to be used with a transcutaneous blood gas monitor to measure a patient's blood partial pressure of oxygen (pO2), blood partial pressure of carbon dioxide (pCO2), and/or blood oxygen saturation transcutaneously (through the skin). Gases diffuse through the skin and into this sensor at the skin surface, where it transmits electrical signals to the parent device for analysis. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
CIG DIAZO COLORIMETRY, BILIRUBIN
CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
JGS ELECTRODE, ION SPECIFIC, SODIUM
CGA GLUCOSE OXIDASE, GLUCOSE
MQM BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
KHP ACID, LACTIC, ENZYMATIC METHOD
KQI ASSAY, FETAL HEMOGLOBIN
GHS ASSAY, CARBOXYHEMOGLOBIN
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
JFP ELECTRODE, ION SPECIFIC, CALCIUM
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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
Storage Environment Temperature: between 2 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
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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