DEVICE: Cleaning Solution with additive S8375 REF 944-126 (05700699441263)

Device Identifier (DI) Information

Cleaning Solution with additive S8375 REF 944-126
944-126
In Commercial Distribution
944-126
Radiometer Medical ApS
05700699441263
GS1

1
308667539 *Terms of Use
S8375 Cleaning Solution 175mL for ABL8XX
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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?
59058 Wash/cleaning solution IVD, automated/semi-automated system
A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KHP ACID, LACTIC, ENZYMATIC METHOD
CGA GLUCOSE OXIDASE, GLUCOSE
JFP ELECTRODE, ION SPECIFIC, CALCIUM
CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE
MQM BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
CIG DIAZO COLORIMETRY, BILIRUBIN
CHL Electrode measurement, blood-gases (pco2, po2) and blood ph
GHS ASSAY, CARBOXYHEMOGLOBIN
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
KQI ASSAY, FETAL HEMOGLOBIN
JGS ELECTRODE, ION SPECIFIC, SODIUM
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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
Special Storage Condition, Specify: Single use
Storage Environment Temperature: between 2 and 25 Degrees Celsius
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Clinically Relevant Size

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

f98224c8-4caa-40a1-938e-910427e0f72a
October 22, 2018
1
September 21, 2018
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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
No Package DIs found
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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

[?]
+45999999999
radiometer@radiometer.dk
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