ADVIA Centaur® Systems iPTH Calibrator 10492394

GUDID 00630414579207

PTH Intact - CENTAUR - CAL - 2x2x1mL

Siemens Healthcare Diagnostics Inc.

Parathyroid hormone (PTH) IVD, calibrator

• Primary Device ID: 00630414579207
• NIH Device Record Key: 9e7c4b7d-46ef-4c3a-b545-dbe753d876d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADVIA Centaur® Systems iPTH Calibrator
• Version Model Number: 10492394
• Catalog Number: 10492394
• 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: true
• 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: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright
• Special Storage Condition, Specify: Between 0 and 0 *Store below -20 deg C & Store Upright

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414579207 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020217

FDA Product Code

• JIT: CALIBRATOR, SECONDARY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-23
• Device Publish Date: 2016-09-24

On-Brand Devices [ADVIA Centaur® Systems iPTH Calibrator]

• 00630414579207: PTH Intact - CENTAUR - CAL - 2x2x1mL
• 00630414579191: PTH Intact - CENTAUR - CAL - 6x2x1mL
• 00630414472553: Intact PTH - CENTAUR - CAL - 2x2x1mL