FDA.reportPublic FDA data

EPOC BGEM CREA TEST CARD, VET, HESKA

Primary DI
00809708086145
Brand
EPOC BGEM CREA TEST CARD, VET, HESKA
Company
Epocal Inc
Model
CT-1007-US-00
Published
2016-08-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00809708086145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00809708086145008097080861458097080861450809708086145

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
201179681
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration 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
00809708053901HOST 2, EPOC, REFURBISHEDHH-1R09-00-00HH-1R09-00-002016-07-05