DEVICE: Calibration Solution (05700699440211)
Device Identifier (DI) Information
Calibration Solution
944-021
In Commercial Distribution
944-021
Radiometer Medical ApS
944-021
In Commercial Distribution
944-021
Radiometer Medical ApS
S7770 tHb calibration Solution (box of 4 ampoules), 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? |
---|---|---|---|---|
35933 | Multiple blood gas analyte IVD, calibrator |
A material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple blood gas analytes in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH |
CGZ | ELECTRODE, ION-SPECIFIC, CHLORIDE |
JFP | ELECTRODE, ION SPECIFIC, CALCIUM |
GKF | INSTRUMENT, HEMATOCRIT, AUTOMATED |
CGA | GLUCOSE OXIDASE, GLUCOSE |
KHP | ACID, LACTIC, ENZYMATIC METHOD |
CIG | DIAZO COLORIMETRY, BILIRUBIN |
CEM | ELECTRODE, ION SPECIFIC, POTASSIUM |
MQM | BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM |
JGS | ELECTRODE, ION SPECIFIC, SODIUM |
JJS | CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep away from sunlight |
Storage Environment Temperature: between 2 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
8a664a0a-11b0-4b37-87a1-ff96b4da1890
July 02, 2024
4
September 01, 2016
July 02, 2024
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:
55700699440216
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+459999999999
radiometer@radiometer.dk
radiometer@radiometer.dk