Dade® Hepzyme®

Basic Information

• Brand Name: Dade® Hepzyme®
• Primary DI: 00842768004049
• Version / Model: 10445730
• Catalog Number: B4240-10
• Company Name: Siemens Healthcare Diagnostics Products GmbH
• Labeler DUNS: 388240673
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2021-11-18
• Public Version Status: Update
• Public Device Record Key: ad6f1855-0c24-4f20-a079-229b3035c54f

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JBR	TEST, HEPARIN NEUTRALIZATION	Hematology	864.7525	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56207	Coagulation inhibitory substance neutralization IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the neutralization of any coagulation inhibitory substances in a clinical specimen through the addition of phospholipids. This is performed prior to testing using an activated partial thromboplastin time (APTT) test.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842768004049	GS1
Unit of Use	00842768019487	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K925452	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius