George King Coumadin® Plasma

GUDID 00815696021280

George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabilized on Coumadin® therapy and is intended for use as a control in the quantitative determination of the INR using the clottable prothrombin time assay.

GEORGE KING BIO-MEDICAL, INC

Prothrombin time (PT) IVD, control

• Primary Device ID: 00815696021280
• NIH Device Record Key: 3c9ca7f6-435d-43ac-899f-f295d079d918
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: George King Coumadin® Plasma
• Version Model Number: 4000-200.0
• Company DUNS: 066761271
• Company Name: GEORGE KING BIO-MEDICAL, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *-70C or colder
• Special Storage Condition, Specify: Between 0 and 0 *-70C or colder
• Special Storage Condition, Specify: Between 0 and 0 *-70C or colder
• Special Storage Condition, Specify: Between 0 and 0 *-70C or colder
• Special Storage Condition, Specify: Between 0 and 0 *-70C or colder
• Special Storage Condition, Specify: Between 0 and 0 *-70C or colder
• Special Storage Condition, Specify: Between 0 and 0 *-70C or colder
• Special Storage Condition, Specify: Between 0 and 0 *-70C or colder
• Special Storage Condition, Specify: Between 0 and 0 *-70C or colder
• Special Storage Condition, Specify: Between 0 and 0 *-70C or colder
• Special Storage Condition, Specify: Between 0 and 0 *-70C or colder
• Special Storage Condition, Specify: Between 0 and 0 *-70C or colder
• Special Storage Condition, Specify: Between 0 and 0 *-70C or colder
• Special Storage Condition, Specify: Between 0 and 0 *-70C or colder
• Special Storage Condition, Specify: Between 0 and 0 *-70C or colder
• Special Storage Condition, Specify: Between 0 and 0 *-70C or colder

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815696021280 [Primary]

FDA Product Code

• GGN: Plasma, Coagulation Control

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-28
• Device Publish Date: 2022-01-20

On-Brand Devices [George King Coumadin® Plasma]

• 00815696020429: George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabiliz
• 00815696020146: George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabiliz
• 00815696021136: George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabiliz
• 00815696021129: George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabiliz
• 00815696021280: George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabiliz