Dimension Vista Barcode Labels KS866

GUDID 00842768024719

Dimension Vista Barcode Labels

Siemens Healthcare Diagnostics Inc.

Printer label IVD
Primary Device ID00842768024719
NIH Device Record Key2f69a4ca-cce2-4481-ac79-61a7dd38acd9
Commercial Distribution StatusIn Commercial Distribution
Brand NameDimension Vista Barcode Labels
Version Model Number10464353
Catalog NumberKS866
Company DUNS005088112
Company NameSiemens Healthcare Diagnostics Inc.
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 Batchtrue
Serial Numberfalse
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(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)441-9250
EmailCONTACT@SIEMENS-HEALTHINEERS.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100842768024719 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-01-19
Device Publish Date2020-11-13

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00630414650623 - Atellica IM 1600 Analyzer2025-03-24 Recertified Atellica IM 1600 Analyzer
00630414313429 - Atellica CH Diazo Direct Bilirubin (D_DBil)2024-10-24 Atellica CH Diazo Direct Bilirubin (D_TBil)
00630414313436 - Atellica CH Diazo Total Bilirubin (D_TBil)2024-10-24 Atellica CH Diazo Total Bilirubin (D_TBil)
00630414317472 - Atellica Connect2024-09-19

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