DEVICE: Electrode for ABL analyzers (05700699456199)
Device Identifier (DI) Information
Electrode for ABL analyzers
945-619
In Commercial Distribution
945-619
Radiometer Medical ApS
945-619
In Commercial Distribution
945-619
Radiometer Medical ApS
E7077 Lactate electrode for ABL7XX/8XX
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
30208 | Lactate electrode IVD |
An electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of lactate ions in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KHP | ACID, LACTIC, ENZYMATIC METHOD |
KQI | ASSAY, FETAL HEMOGLOBIN |
CGL | ELECTRODE, ION BASED, ENZYMATIC, CREATININE |
JGS | ELECTRODE, ION SPECIFIC, SODIUM |
GHS | ASSAY, CARBOXYHEMOGLOBIN |
CGA | GLUCOSE OXIDASE, GLUCOSE |
CIG | DIAZO COLORIMETRY, BILIRUBIN |
CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH |
CEM | ELECTRODE, ION SPECIFIC, POTASSIUM |
MQM | BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM |
JFP | ELECTRODE, ION SPECIFIC, CALCIUM |
CGZ | ELECTRODE, ION-SPECIFIC, CHLORIDE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
49c3d934-9a46-46d6-b432-46d6bfccc343
March 19, 2021
4
September 01, 2016
March 19, 2021
4
September 01, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+459999999999
radiometer@radiometer.dk
radiometer@radiometer.dk