George King Prekallikrein Deficient Plasma

Basic Information

• Brand Name: George King Prekallikrein Deficient Plasma
• Primary DI: 00815696020726
• Version / Model: 1700-1.5
• Company Name: GEORGE KING BIO-MEDICAL, INC
• Labeler DUNS: 066761271
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-18
• Public Version: 4
• Public Version Date: 2023-04-03
• Public Version Status: Update
• Public Device Record Key: e5ea6850-6eda-4242-bdfc-cdd5ea2b2db4
• Distribution End Date: 2023-04-01

Device Description

George King Prekallikrein Deficient plasma is fresh frozen citrated human plasma derived from congenital Prekallikrein Deficient donors.

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
56072	Coagulation factor prekallikrein/kallikrein 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 prekallikrein or kallikrein, also known as Fletcher factor, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815696020726	GS1

Customer Contacts

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