DEVICE: S5362 REF 943-906 (05700699439062)

Device Identifier (DI) Information

S5362 REF 943-906
943-906
In Commercial Distribution
943-906
Radiometer Medical ApS
05700699439062
GS1

1
308667539 *Terms of Use
S5362 Hypochlorit Solution for protein Removal and decontamination 100mL for BPH5, ABL5/50/5XX, EML10X ABL8XX
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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?
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
JFP ELECTRODE, ION SPECIFIC, CALCIUM
JGS ELECTRODE, ION SPECIFIC, SODIUM
KHP ACID, LACTIC, ENZYMATIC METHOD
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
CIG DIAZO COLORIMETRY, BILIRUBIN
CGA GLUCOSE OXIDASE, GLUCOSE
KQI ASSAY, FETAL HEMOGLOBIN
CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE
GHS ASSAY, CARBOXYHEMOGLOBIN
CHL Electrode measurement, blood-gases (pco2, po2) and blood ph
MQM BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
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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 8 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight
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Clinically Relevant Size

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

57716c29-4fd3-46e4-ae75-5045f6a96210
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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