DEVICE: epoc NXS Host (00630414606095)

Device Identifier (DI) Information

epoc NXS Host
11413475
In Commercial Distribution
16266
Epocal Inc
00630414606095
GS1

1
201179681 *Terms of Use
The epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for thequantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratoryor at the point of care in hospitals, nursing homes or other clinical care institutions.
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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?
56667 Metabolic profile clinical chemistry analyser IVD
A portable, electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemistry analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters (e.g., pO2, pCO2), electrolytes [e.g., Sodium (Na2+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine and sometimes in addition haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)].
Active false
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FDA Product Code

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Product Code Product Code Name
KHP ACID, LACTIC, ENZYMATIC METHOD
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
JGS ELECTRODE, ION SPECIFIC, SODIUM
JFP ELECTRODE, ION SPECIFIC, CALCIUM
CHL Electrode measurement, blood-gases (pco2, po2) and blood ph
JFL pH rate measurement, carbon-dioxide
CGA GLUCOSE OXIDASE, GLUCOSE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K200107 000
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Sterilization

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

[?]
Storage and Handling
Storage Environment Humidity: between 0 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 70 Degrees Celsius
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Clinically Relevant Size

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

077a07f6-60de-462a-9ee1-21d1c23d2750
September 16, 2022
4
June 18, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(877)229-3711
CONTACT@SIEMENS-HEALTHINEERS.COM
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