ADVIA Chemistry Systems 70-mL Wedges - Yellow 11223140

GUDID 00630414168258

ADVIA Chemistry Systems 70-mL Wedges –Yellow

Siemens Healthcare Diagnostics Inc.

Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use Assay container IVD, single-use

• Primary Device ID: 00630414168258
• NIH Device Record Key: df48e85d-3b7d-4b23-abd4-b3602ce44ffa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADVIA Chemistry Systems 70-mL Wedges - Yellow
• Version Model Number: 11223140
• Catalog Number: 11223140
• Company DUNS: 064608573
• Company Name: Siemens Healthcare Diagnostics Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414168258 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990346

FDA Product Code

• JJE: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-09
• Device Publish Date: 2022-04-30

Devices Manufactured by Siemens Healthcare Diagnostics Inc.

• 00630414313450 - Atellica CH Billirubin Calibrator (BILI CAL): 2024-04-11 Atellica CH Bilirubin Calibrator (BILI CAL)
• 00630414317427 - Clinistix UTI Test Strips: 2024-02-29 Test strips for urinary tract infection
• 00630414626963 - ADVIA Centaur NT-PBNPII (PBNPII): 2024-02-13 PBNPII - ADVIA Centaur - MCM Set
• 00630414626970 - ATELLICA IM NT-PBNPII (PBNPII): 2024-02-13 PBNPII - ATELLICA IM - MCM Set
• 00630414284927 - ADVIA Centaur PBNPII: 2024-02-12 NT-proBNPII (PBNPII) - ADVIA Centaur - RGT - 100T
• 00630414284934 - ADVIA Centaur PBNPII: 2024-02-12 NT-proBNPII (PBNPII) - ADVIA Centaur - RGT - 500T
• 00630414284941 - Atellica IM PBNPII: 2024-02-12 NT-proBNPII (PBNPII) - Atellica IM - RGT - 100T
• 00630414284958 - Atellica IM PBNPII: 2024-02-12 NT-proBNPII (PBNPII) - Atellica IM - RGT - 500T