BFT II Analyzer Dispo System OVKG03

GUDID 00842768012259

The cuvettes serve coagulation tests as a reaction vessel.

Siemens Healthcare Diagnostics Products GmbH

Coagulation analyser IVD, laboratory, semi-automated
Primary Device ID00842768012259
NIH Device Record Key334108fd-1ec9-4bd6-925f-aa991a1dae14
Commercial Distribution StatusIn Commercial Distribution
Brand NameBFT II Analyzer Dispo System
Version Model Number10446530
Catalog NumberOVKG03
Company DUNS388240673
Company NameSiemens Healthcare Diagnostics Products GmbH
Device Count500
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)242-3233
EmailXX@XX.XX
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)242-3233
EmailCONTACT@SIEMENS-HEALTHINEERS.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100842768012259 [Primary]
GS100842768024979 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

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 Number3
Public Version Date2018-07-06
Device Publish Date2017-10-31

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