George King Single Donor Normal Plasma

GUDID 00815696021303

George King Single Donor Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for the one-stage prothrombin time (PT) assay, the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay.

GEORGE KING BIO-MEDICAL, INC

Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control Multiple coagulation factor IVD, control

• Primary Device ID: 00815696021303
• NIH Device Record Key: e1cabf6e-22f2-4ec4-9267-ae2b037a05ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: George King Single Donor Normal Plasma
• Version Model Number: 0001-60.0
• Company DUNS: 066761271
• Company Name: GEORGE KING BIO-MEDICAL, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815696021303 [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: 2022-03-11
• Device Publish Date: 2022-03-03

On-Brand Devices [George King Single Donor Normal Plasma]

• 00815696021105: George King Single Donor Normal Plasma is fresh frozen citrated human plasma and is intended to
• 00815696020603: George King Single Donor Normal Plasma is fresh frozen human citrated plasma and is intended to
• 00815696020559: George King Single Donor Normal Plasma is fresh frozen citrared human plasma and is intended to
• 00815696020160: George King Single Donor Normal Plasma is fresh frozen human citrated plasma and is intended to
• 00815696020153: George King Single Donor Normal Plasma is fresh frozen citrated human plasma and is intended to
• 00815696021228: George King Single Donor Normal Plasma is fresh frozen citrated human plasma and is intended to
• 00815696021303: George King Single Donor Normal Plasma is fresh frozen citrated human plasma and is intended to