George King Factor VIII Deficient Plasma with Inhibitor

Basic Information

• Brand Name: George King Factor VIII Deficient Plasma with Inhibitor
• Primary DI: 00815696021174
• Version / Model: 1800-100
• 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: 2019-09-10
• Public Version: 1
• Public Version Date: 2019-09-18
• Public Version Status: New
• Public Device Record Key: 0655c9b0-c33e-4cc7-a6eb-95e721058152

Device Description

George King Factor VIII Deficient Plasma with Inhibitor is fresh frozen citrated human plasma derived from a congenital Factor VIII deficient donor who has developed an antibody to FVIII.

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
GGN	Plasma, Coagulation Control	Hematology	864.5425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56171	Coagulation factor VIII inhibitor IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of coagulation factor VIII inhibitor in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815696021174	GS1

Customer Contacts

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

Storage Conditions

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