George King Coumadin® Plasma Convenience Kit

GUDID 00815696021099

The George King Coumadin® Plasma Kit is a convenience control kit that contains citrated human fresh frozen plasma from donors on Coumadin® therapy. Each kit contains control material with six different INR levels.

GEORGE KING BIO-MEDICAL, INC

Prothrombin time (PT) IVD, control

• Primary Device ID: 00815696021099
• NIH Device Record Key: 30631cd2-1023-4562-b122-013527d5b15c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: George King Coumadin® Plasma Convenience Kit
• Version Model Number: 0090-30
• 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: true
• 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: 800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 800-255-5108
• Email: plasma@kingbiomed.com
• Phone: 800-255-5108
• Email: plasma@kingbiomed.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815696021099 [Primary]

FDA Product Code

• GGN: Plasma, Coagulation Control

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-07-24

Devices Manufactured by GEORGE KING BIO-MEDICAL, INC

• 00815696021327 - George King Heparin Control Plasma: 2025-07-21 George King (GK) Heparin Control Plasma is an assayed citrated plasma intended for the control of Unfractionated Heparin (UFH) a
• 00815696021341 - George King SysCOR-40 Control Kit: 2023-03-23 SysCOR-40 Control Kit is a system control convenience kit containing 20 normal and 20 abnormal plasma controls to assist with in
• 00815696021297 - George King Pooled Normal Plasma: 2022-03-11 George King Pooled Normal Plasma is fresh frozen citrated human plasma is intended to be used as a normal control for the one-st
• 00815696021303 - George King Single Donor Normal Plasma: 2022-03-11 George King Single Donor Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for
• 00815696021310 - George King Factor VIII Deficient Plasma: 2022-03-11 George King Factor VIII Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor VIII Deficient don
• 00815696021280 - George King Coumadin® Plasma: 2022-01-28 George King Coumadin® Plasma is citrated fresh frozen human plasma derived from donors stabilized on Coumadin® therapy and is
• 00815696021266 - George King von Willebrand Plasma, Type 2B: 2021-04-05 George King von Willebrand plasma, Type 2B, is a citrated human fresh frozen plasma derived from a donor diagnosed with vWD Type
• 00815696021259 - George King Pooled Normal Plasma: 2021-01-18 George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for the on