KC® 4 Delta

GUDID 05391521421012

TCOAG IRELAND LIMITED

Coagulation analyser IVD, laboratory, semi-automated
Primary Device ID05391521421012
NIH Device Record Key7e1a7306-3a70-4a60-9f41-9f8a4f404c27
Commercial Distribution StatusIn Commercial Distribution
Brand NameKC® 4 Delta
Version Model NumberN04000
Company DUNS985039126
Company NameTCOAG IRELAND LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105391521421012 [Primary]

FDA Product Code

JPASystem, Multipurpose For In Vitro Coagulation Studies

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-12

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15391521420630 - TriniCHECK Level 12019-07-08
15391521420647 - TriniCHECK Level 22019-07-08
15391521420654 - TriniCHECK Level 32019-07-08
15391521421309 - DT Wash2019-07-08
15391521421729 - DT Fluid2019-07-08

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