George King von Willebrand Plasma Type 2B

Basic Information

• Brand Name: George King von Willebrand Plasma Type 2B
• Primary DI: 00815696020641
• Version / Model: 1402-1.0
• Company Name: GEORGE KING BIO-MEDICAL, INC
• Labeler DUNS: 066761271
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-18
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 85d9f89b-fbe7-43a6-a56b-0b7f0e610f7d

Device Description

George King von Willebrand plasma, Type 2B, is citrated fresh frozen human plasma derived from a donor diagnosed with vWD Type 2B. This plasma is intended for use as a control in the quantitative determination of von Willebrand Ag in citrated plasma.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• 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
GGC	Control, Plasma, Abnormal	Hematology	864.5425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56029	Coagulation factor VIII-associated antigen IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of coagulation factor VIII-associated antigen, also known as von Willebrand antigen, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815696020641	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: -70˚C or below