VersaCell® X3 10793839

GUDID 00630414595177

VERSACELL X3 Instrument

SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS

Specimen processing instrument IVD, automated
Primary Device ID00630414595177
NIH Device Record Key19e74a30-2cf9-4414-903a-cc3ceb65d4c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameVersaCell® X3
Version Model Number10793839
Catalog Number10793839
Company DUNS186812384
Company NameSIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414595177 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-25
Device Publish Date2018-09-24

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00630414974194 - IMMULITE® 1000 Systems1000 Sample Cup Caps2020-10-02
00630414973937 - IMMULITE® 2000 Systems Microsampling Tubes2019-02-06 Microsampling Tubes - IMMULITE - CONS - 1000 Pieces
00630414974187 - IMMULITE®/IMMULITE® 1000 Systems SAMPLE CUPS2019-02-04 IMMULITE Sample Cups(1000/pack) - IMMULITE - CONS - 1000 Pieces
00630414947440 - IMMULITE® 1000 Immunoassay System2019-01-23 IMMULITE® 1000 Instrument, 110 VOLT
00630414595177 - VersaCell® X32018-10-25VERSACELL X3 Instrument
00630414595177 - VersaCell® X32018-10-25 VERSACELL X3 Instrument

Trademark Results [VersaCell]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VERSACELL
VERSACELL
77379173 3841983 Live/Registered
Siemens Healthcare Diagnostics Inc.
2008-01-24
VERSACELL
VERSACELL
75085727 2054885 Dead/Cancelled
SUN CHEMICAL CORPORATION
1996-04-09

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