Calcium Chloride Solution 10873872

GUDID 00842768018916

Supplementary Reagent for coagulation tests

Siemens Healthcare Diagnostics Products GmbH

Calcium chloride coagulation reagent IVD

• Primary Device ID: 00842768018916
• NIH Device Record Key: 6405e5d8-0626-4ae3-a2a2-869fcf4b04bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calcium Chloride Solution
• Version Model Number: 10873872
• Catalog Number: 10873872
• Company DUNS: 388240673
• Company Name: Siemens Healthcare Diagnostics Products GmbH
• Device Count: 10
• 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(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)242-3233
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414640563 [Primary]
GS1	00842768018916 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924509

FDA Product Code

• JPA: SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

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: 2024-04-02
• Device Publish Date: 2024-03-25

On-Brand Devices [Calcium Chloride Solution]

• 00842768014222: Supplementary Reagent for coagulation tests
• 00842768018916: Supplementary Reagent for coagulation tests