AptioTM Automation APT-201-01

GUDID 00630414596754

APTIO INPUT/OUTPUT MODULE W/O SLOT

Siemens Healthcare Diagnostics Inc.

Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD

• Primary Device ID: 00630414596754
• NIH Device Record Key: e42d7ba1-86ce-41e5-9885-414b8c56fd66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AptioTM Automation
• Version Model Number: 10713760
• Catalog Number: APT-201-01
• Company DUNS: 005088112
• 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: false
• Serial Number: true
• 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: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• 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
• 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	00630414596754 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083339

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: 2018-10-25
• Device Publish Date: 2018-09-24

Devices Manufactured by Siemens Healthcare Diagnostics Inc.

• 00630414306438 - ADVIA CHEM Ecre3: 2024-04-26 Creatinine enzymatic - ADVIA Chem. - RGT
• 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