Dade® Hepzyme® B4240-10

GUDID 00842768004049

Heparin neutralizer in plasma to rule out heparin contamination in coagulation testing

Siemens Healthcare Diagnostics Products GmbH

Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent Coagulation inhibitory substance neutralization IVD, reagent

• Primary Device ID: 00842768004049
• NIH Device Record Key: ad6f1855-0c24-4f20-a079-229b3035c54f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dade® Hepzyme®
• Version Model Number: 10445730
• Catalog Number: B4240-10
• 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: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• Phone: +1(800)242-3233
• Email: XX@XX.XX
• 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 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	00842768004049 [Primary]
GS1	00842768019487 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K925452

FDA Product Code

• JBR: TEST, HEPARIN NEUTRALIZATION

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

Devices Manufactured by Siemens Healthcare Diagnostics Products GmbH

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• 00842768019654 - LA 1 Screening Reagent: 2024-04-08 LA 1 Screening Reagent. Simplified DRVV reagent to screen for the presence of Lupus Anticoagulants
• 00842768019678 - LA Control Low: 2024-04-08 LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays
• 00842768019685 - LA Control High: 2024-04-08 LA Control High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays
• 00630414640433 - vWF Ag: 2024-04-08 For the quantitative determination of von Willebrand factor (vWF) antigen concentration in human sodium citrated plasma
• 00630414639352 - Berichrom Plasminogen: 2024-04-02 Quantitative determination of plasminogen activity as an aid in the diagnosis and monitoring of fibrinolytic disorders
• 00630414639437 - Berichrom a2-Antiplasmin: 2024-04-02 Quantative determination of a2-antiplasmin activity as an aid in the diagnosis of inherited or acquired deficiencies and in mana
• 00630414639444 - Berichrom Antithrombin III (A): 2024-04-02 Determination of the functional activity of antithrombin III (AT III) in human plasma