DEVICE: Crea Calibration Solution 1 (05700699441331)

Device Identifier (DI) Information

Crea Calibration Solution 1
944-133
In Commercial Distribution
944-133
Radiometer Medical ApS
05700699441331
GS1

1
308667539 *Terms of Use
S1827 Crea Calibration Solution 1, membrane bottle, 6x175 mL, for ABL8XX, JAP/ROW
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
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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
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 10 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

33a90728-bd24-412b-865e-b9ccaccc21c4
July 02, 2024
4
September 01, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+459999999999
radiometer@radiometer.dk
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