Stratus® CS Acute Care™ CardioPhase® High Sensitivity C-reactive Protein CalPak CCCRP-C

GUDID 00842768004476

The Stratus® CS Acute Care™ CardioPhase® High Sensitivity C-reactive Protein Calibrator (CCRP CalPak) is an in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus® CS analyzer.

Siemens Healthcare Diagnostics Inc.

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• Primary Device ID: 00842768004476
• NIH Device Record Key: 557b444e-9692-4c7e-bcaa-cf1df16a09f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stratus® CS Acute Care™ CardioPhase® High Sensitivity C-reactive Protein CalPak
• Version Model Number: 10445067
• Catalog Number: CCCRP-C
• Company DUNS: 005088112
• Company Name: Siemens Healthcare Diagnostics Inc.
• Device Count: 5
• 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: true
• 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: true

Customer Support Contacts

• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: XX@XX.XX
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)405-6473
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414009810 [Unit of Use]
GS1	00842768004476 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984067

FDA Product Code

• JHX: FLUOROMETRIC METHOD, CPK OR ISOENZYMES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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