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 Prothrombin time (PT) IVD, control Prothrombin time (PT) IVD, control Prothrombin time (PT) IVD, control Prothrombin time (PT) IVD, control Prothrombin time (PT) IVD, control Prothrombin time (PT) IVD, control Prothrombin time (PT) IVD, control Prothrombin time (PT) IVD, control Prothrombin time (PT) IVD, control Prothrombin time (PT) IVD, control Prothrombin time (PT) IVD, control Prothrombin time (PT) IVD, control Prothrombin time (PT) IVD, control Prothrombin time (PT) IVD, control 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