FDA.reportPublic FDA data

epoc NXS Host

Primary DI
00630414606095
Brand
epoc NXS Host
Company
Epocal Inc
Model
11413475
Catalog number
16266
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.
Published
2020-06-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CEMELECTRODE, ION SPECIFIC, POTASSIUM
CGAGLUCOSE OXIDASE, GLUCOSE
CGZELECTRODE, ION-SPECIFIC, CHLORIDE
CHLElectrode measurement, blood-gases (pco2, po2) and blood ph
JFLpH rate measurement, carbon-dioxide
JFPELECTRODE, ION SPECIFIC, CALCIUM
JGSELECTRODE, ION SPECIFIC, SODIUM
KHPACID, LACTIC, ENZYMATIC METHOD

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2
CGAGlucose Oxidase, GlucoseClinical Chemistry2
CGZElectrode, Ion-Specific, ChlorideClinical Chemistry2
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhClinical Chemistry2
JFLPh Rate Measurement, Carbon-DioxideClinical Chemistry2
JFPElectrode, Ion Specific, CalciumClinical Chemistry2
JGSElectrode, Ion Specific, SodiumClinical Chemistry2
KHPAcid, Lactic, Enzymatic MethodClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200107000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200107000epoc Blood Analysis SystemEpocal, Inc.2020-06-05CHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414606095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414606095006304146060956304146060950630414606095

GMDN Terms#

Term, Definition table
TermDefinition
Metabolic profile clinical chemistry analyser IVD, portable, automatedA portable mains electricity (AC-powered) laboratory instrument, typically with rechargeable batteries for power at the point-of-care in acute care settings, intended 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 haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)]. It operates with minimal technician involvement and automation of all procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
201179681
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414606460epoc Host211413524114135242020-07-15
00809708016678EPOC HOST MOBILE COMPUTERHH-0003-00-00HH-0003-00-002016-07-05
00809708016685EPOC READERHR-1002-00-00HR-1002-00-002016-07-05
00809708032333EPOC READER, REFURBISHEDHR-1R02-00-00HR-1R02-00-002016-07-05
00809708032340EPOC HOST, REFURBISHEDHH-0R03-00-00HH-0R03-00-002016-07-05
00809708039417EPOC READER, VETERINARY, CEHR-1003-00-002016-07-05
00809708040659EPOC READER, VETERINARY, CE, REFURBISHEDHR-1R03-00-002016-07-05
00809708040666EPOC HOST, VETERINARY, CE, REFURBISHEDHH-0R04-00-002016-07-05
00809708046514EPOC HOST MOBILE COMPUTER, INT'LHH-0003-XU-002016-07-05
00809708046521EPOC HOST, INT'L, REFURBHH-0R03-XU-002016-07-05
00809708049379EPOC HOST, RXHH-0005-00-00HH-0005-00-002016-07-05
00809708049386EPOC HOST, RX, REFURBHH-0R05-00-00HH-0R05-00-002016-07-05
00809708049393EPOC HOST, RX, INT'LHH-0005-XU-00HH-0005-XU-002016-07-05
00809708049409EPOC HOST, RX, INT'L, REFURBHH-0R05-XU-00HH-0R05-XU-002016-07-05
00809708049423EPOC HOST, RX, VET, INT'L, REFURBHH-0R07-00-002016-07-05
00809708051839EPOC HOST, RX, VET, NA, REFURBHH-0R08-00-002016-07-05
00809708052898HOST 2, EPOCHH-1009-00-00HH-1009-00-002016-07-05
00809708052911HOST 2, EPOC, VETERINARYHH-1010-00-002016-07-05
00809708053901HOST 2, EPOC, REFURBISHEDHH-1R09-00-00HH-1R09-00-002016-07-05
00809708053918HOST 2, EPOC, VETERINARY, REFURBISHEDHH-1R10-00-002016-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719869706904Tyson Bio AC500 PRO Blood Glucose Monitoring System (Meter Only) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706911TysonBio AC500 PRO Blood Glucose Test Strips (50T)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706959Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
05700693930978ABL90 FLEXRadiometer Medical ApSCGA2026-07-09
05700693930978ABL90 FLEXRadiometer Medical ApSJGS2026-07-09
05700693930978ABL90 FLEXRadiometer Medical ApSJFP2026-07-09
05700693930978ABL90 FLEXRadiometer Medical ApSCHL2026-07-09
05700693930978ABL90 FLEXRadiometer Medical ApSKHP2026-07-09
05700693930978ABL90 FLEXRadiometer Medical ApSCGZ2026-07-09
05700693930978ABL90 FLEXRadiometer Medical ApSCEM2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCHL2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCGZ2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSKHP2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSJGS2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSJFP2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCEM2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCGA2026-07-09
05700699446572SP90Radiometer Medical ApSCHL2026-07-09
05700699446572SP90Radiometer Medical ApSCGZ2026-07-09
05700699446572SP90Radiometer Medical ApSJGS2026-07-09
05700699446572SP90Radiometer Medical ApSCGA2026-07-09
05700699446572SP90Radiometer Medical ApSKHP2026-07-09
05700699446572SP90Radiometer Medical ApSJFP2026-07-09
05700699446572SP90Radiometer Medical ApSCEM2026-07-09
05700699447579SP90Radiometer Medical ApSCEM2026-07-09
05700699447579SP90Radiometer Medical ApSJGS2026-07-09
05700699447579SP90Radiometer Medical ApSKHP2026-07-09
05700699447579SP90Radiometer Medical ApSCGA2026-07-09
05700699447579SP90Radiometer Medical ApSJFP2026-07-09