DEVICE: D8088+D8089 Crea membrane A+B (05700699420732)
Device Identifier (DI) Information
D8088+D8089 Crea membrane A+B
942-073
In Commercial Distribution
942-073
Radiometer Medical ApS
942-073
In Commercial Distribution
942-073
Radiometer Medical ApS
D8088+D8089 Crea membrane box A+B, with 2xA and 2xB membrane units, for ABL8XX
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
53252 | Creatinine IVD, reagent |
A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of creatinine in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CGL | ELECTRODE, ION BASED, ENZYMATIC, CREATININE |
CGZ | ELECTRODE, ION-SPECIFIC, CHLORIDE |
MQM | BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM |
CEM | ELECTRODE, ION SPECIFIC, POTASSIUM |
CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH |
KQI | ASSAY, FETAL HEMOGLOBIN |
CGA | GLUCOSE OXIDASE, GLUCOSE |
JFP | ELECTRODE, ION SPECIFIC, CALCIUM |
JGS | ELECTRODE, ION SPECIFIC, SODIUM |
GHS | ASSAY, CARBOXYHEMOGLOBIN |
CIG | DIAZO COLORIMETRY, BILIRUBIN |
KHP | ACID, LACTIC, ENZYMATIC METHOD |
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 10 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
b4fa3529-cf50-4d5b-ba15-05bb4a1c1f15
December 20, 2022
4
September 01, 2016
December 20, 2022
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