FDA.reportPublic FDA data

epoc Host2

Primary DI
00630414606460
Brand
epoc Host2
Company
Epocal Inc
Model
11413524
Catalog number
11413524
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 laboratory orat the point of care in hospitals, nursing homes or other clinical care institutions.
Published
2020-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
GIOTUBE, COLLECTION, CAPILLARY BLOOD
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
GIOTube, Collection, Capillary BloodHematology1
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
K061597000
K090109000
K092849000
K093297000
K113726000
K171247000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061597000EPOC BLOOD ANALYSIS SYSTEMEpocal, Inc.2006-09-27JGS
K090109000BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARDEpocal, Inc.2009-06-24CGA
K092849000BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZEREpocal, Inc.2010-03-30CEM
K093297000EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBEEpocal, Inc.2010-06-09KHP
K113726000EPOC CHLORIDE TEST AND EPOC CREATININE TESTEpocal, Inc.2012-10-05CGL
K171247000epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide TestEpocal, Inc.2018-01-17CDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414606460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414606460006304146064606304146064600630414606460

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414606095epoc NXS Host11413475162662020-06-18
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

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