EPOC BGEM BUN TEST CARD 10736515

GUDID 00809708121860

Epocal Inc

Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
Primary Device ID00809708121860
NIH Device Record Key40cf7eca-d054-44ac-802c-80bb5d0b8f4a
Commercial Distribution StatusIn Commercial Distribution
Brand NameEPOC BGEM BUN TEST CARD
Version Model Number10736515
Catalog Number10736515
Company DUNS201179681
Company NameEpocal Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100809708121860 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-05-18
Device Publish Date2018-04-17

Devices Manufactured by Epocal Inc

00630414606095 - epoc NXS Host2020-07-24 The epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for thequa
00630414606460 - epoc Host22020-07-23 The epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for thequa
00809708041137 - CAPILLARY TUBE, CARE-FILL, BUNDLE OF 502018-08-09
00809708049232 - TUBE, CAPILLARY, VETERINARY, (BUNDLE 50)2018-08-09
00809708114572 - EDM LITE KIT2018-05-18
00809708121860 - EPOC BGEM BUN TEST CARD2018-05-18
00809708121860 - EPOC BGEM BUN TEST CARD2018-05-18
00809708150303 - EPOC HOST 2, VETERINARY, CHINA2018-05-18
00809708150310 - EPOC HOST 2, VETERINARY, CHINA, REFURBISHED2018-05-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.