INNOVANCE VWF Ac

Basic Information

• Brand Name: INNOVANCE VWF Ac
• Primary DI: 00630414639468
• Version / Model: 10873906
• Catalog Number: 10873906
• Company Name: Siemens Healthcare Diagnostics Products GmbH
• Labeler DUNS: 388240673
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-25
• Public Version: 1
• Public Version Date: 2024-04-02
• Public Version Status: New
• Public Device Record Key: e6d07963-a674-42c2-b33c-edc0ed535522

Device Description

For the quantitative determination of von Willenbrand factor (VWF) GPIb-binding activity in human sodium citrated plasma

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
QTY	von Willebrand factor assay	Hematology	864.7293	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58423	von Willebrand factor:glycoprotein Ib binding activity (vWF:GPIb) IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of von Willebrand factor: glycoprotein Ib binding activity (vWF:GPIb) in a clinical specimen, using a nephelometry/turbidimetry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414639468	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
DEN200067	000

Storage Conditions

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