Stratus® CS Acute Care™ pBNP CalPak CPBNPM-C

GUDID 00842768019722

The Stratus® CS Acute Care™ NT-proBNP Calibrator (pBNP CalPak) is an in vitro diagnostic product intended to be used for the calibration of the Stratus® CS Acute Care™ pBNP method.

Siemens Healthcare Diagnostics Inc.

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassay

• Primary Device ID: 00842768019722
• NIH Device Record Key: 0f532d54-fa84-4f84-9045-624a0b946011
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stratus® CS Acute Care™ pBNP CalPak
• Version Model Number: 10445087
• Catalog Number: CPBNPM-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: false

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: 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 -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414009971 [Unit of Use]
GS1	00842768019722 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060548

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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