FDA.reportPublic FDA data

HOST 2, EPOC, REFURBISHED

Primary DI
00809708053901
Brand
HOST 2, EPOC, REFURBISHED
Company
Epocal Inc
Model
HH-1R09-00-00
Catalog number
HH-1R09-00-00
Published
2016-07-05
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
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
JFPElectrode, Ion Specific, CalciumClinical Chemistry2
JGSElectrode, Ion Specific, SodiumClinical Chemistry2
KHPAcid, Lactic, Enzymatic MethodClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00809708053901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00809708053901008097080539018097080539010809708053901

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.

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
00630414606095epoc NXS Host11413475162662020-06-18
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
00809708053918HOST 2, EPOC, VETERINARY, REFURBISHEDHH-1R10-00-002016-07-05

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