Atellica Connect Test System 11697146

GUDID 00630414317496

Siemens Healthcare Diagnostics Inc.

Medical equipment clinical data interfacing software

• Primary Device ID: 00630414317496
• NIH Device Record Key: c9db95dd-7e8e-4606-9e1a-55ca0abdf69c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atellica Connect Test System
• Version Model Number: 11697146
• Catalog Number: 11697146
• Company DUNS: 064608573
• Company Name: Siemens Healthcare Diagnostics Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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
• 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	00630414317496 [Primary]

FDA Product Code

• JQP: Calculator/data processing module, 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: 2024-09-19
• Device Publish Date: 2024-09-11

Devices Manufactured by Siemens Healthcare Diagnostics Inc.

• 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 Connect: 2024-09-19
• 00630414317489 - Atellica Connect SE: 2024-09-19
• 00630414317496 - Atellica Connect Test System: 2024-09-19
• 00630414317496 - Atellica Connect Test System: 2024-09-19
• 00630414305028 - Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2): 2024-06-19 Atellica CH High Sensitivity C-Reactive Protein (hCRP2) Reagent
• 00630414624488 - ADVIA Centaur TSH3-Ultra II: 2024-05-30 TSH3-ULII ADVIA Centaur - RGT 500T
• 00630414624501 - ADVIA Centaur TSH3-Ultra II: 2024-05-30 TSH3-ULII ADVIA Centaur - RGT (REF) 2500T