Valve Module (unheated) 03372381

GUDID 00630414452142

Valve module an in vitro diagnostics device to be used on the RAPIDChem® 744/754 analyzer

Siemens Healthcare Diagnostics Inc.

Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care Blood gas/haemoximetry analyser IVD, point-of-care
Primary Device ID00630414452142
NIH Device Record Key55ddbd39-3355-4187-a850-c109e215885e
Commercial Distribution StatusIn Commercial Distribution
Brand NameValve Module (unheated)
Version Model Number10309056
Catalog Number03372381
Company DUNS064608573
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 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
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
Phone+1(877)229-3711
EmailXX@XX.XX
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414452142 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CEMELECTRODE, ION SPECIFIC, POTASSIUM

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 Date2016-09-24

Devices Manufactured by Siemens Healthcare Diagnostics Inc.

00630414624488 - ADVIA Centaur TSH3-Ultra II2024-05-30 TSH3-ULII ADVIA Centaur - RGT 500T
00630414624501 - ADVIA Centaur TSH3-Ultra II2024-05-30 TSH3-ULII ADVIA Centaur - RGT (REF) 2500T
00630414624518 - Atellica IM TSH3-Ultra II2024-05-30 TSH3-ULII Atellica IM - RGT 110T
00630414624525 - Atellica IM TSH3-Ultra II2024-05-30 TSH3-ULII Atellica IM – RGT 550T
00630414624532 - Atellica IM TSH3ULII MCM set2024-05-30 TSH3-ULII Atellica IM - Consumable MCM Set
00630414624693 - Atellica IM TSH3-Ultra II2024-05-30 TSH3-ULII Atellica IM - RGT (REF) 2750T
00630414624709 - ADVIA Centaur TSH3ULII MCM SET2024-05-30 TSH3-ULII ADVIA Centaur - Consumable MCM Set
00630414317434 - Clinistix Kidney Health Test System2024-05-13 Test Strips for the Determination of Albumin and Creatinine in Urine

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