DEVICE: Membrane for E1001 electrode (05700699420589)
Device Identifier (DI) Information
Membrane for E1001 electrode
942-058
In Commercial Distribution
942-058
Radiometer Medical ApS
942-058
In Commercial Distribution
942-058
Radiometer Medical ApS
D711 Ref membrane box (4 units) 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? |
---|---|---|---|---|
59241 | Reference electrode IVD |
An electrochemical sensor intended to be used as a known reference for electrical potential in an assay that is used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH |
CGA | GLUCOSE OXIDASE, GLUCOSE |
KQI | ASSAY, FETAL HEMOGLOBIN |
CEM | ELECTRODE, ION SPECIFIC, POTASSIUM |
CIG | DIAZO COLORIMETRY, BILIRUBIN |
CGZ | ELECTRODE, ION-SPECIFIC, CHLORIDE |
MQM | BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM |
GHS | ASSAY, CARBOXYHEMOGLOBIN |
KHP | ACID, LACTIC, ENZYMATIC METHOD |
JFP | ELECTRODE, ION SPECIFIC, CALCIUM |
JGS | ELECTRODE, ION SPECIFIC, SODIUM |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 32 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
bb73e673-bc06-4556-ab20-9bcfa8894742
November 27, 2020
3
September 01, 2016
November 27, 2020
3
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:
55700699420584
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+459999999999
radiometer@radiometer.dk
radiometer@radiometer.dk