AccessGUDID - DEVICE: epoc NXS Host (00630414606095)

GUDID

Device Identifier (DI) Information

Brand Name: epoc NXS Host
Version or Model: 11413475
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 16266
Company Name: Epocal Inc

Primary DI Number: 00630414606095
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 201179681 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

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

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 077a07f6-60de-462a-9ee1-21d1c23d2750
Public Version Date: September 16, 2022
Public Version Number: 4
DI Record Publish Date: June 18, 2020