DEVICE: Crea Calibration Solution 1 (05700699441331)

Download: XML | JSON

Device Identifier (DI) Information

Crea Calibration Solution 1
944-133
944-133
Radiometer Medical ApS
05700699441331
GS1
1
S1827 Crea Calibration Solution 1, membrane bottle, 6x175 mL, for ABL8XX, JAP/ROW
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE
CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
CIG DIAZO COLORIMETRY, BILIRUBIN
KHP ACID, LACTIC, ENZYMATIC METHOD
CGA GLUCOSE OXIDASE, GLUCOSE
GHS ASSAY, CARBOXYHEMOGLOBIN
MQM BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
JFP ELECTRODE, ION SPECIFIC, CALCIUM
JGS ELECTRODE, ION SPECIFIC, SODIUM
KQI ASSAY, FETAL HEMOGLOBIN
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 10 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
September 01, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
15700699441338 6 05700699441331 In Commercial Distribution
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+459999999999
radiometer@radiometer.dk
CLOSE