George King Single Donor Normal Plasma

GUDID 00815696021105

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

• Primary Device ID: 00815696021105
• NIH Device Record Key: 191e4507-40b8-4618-8547-9f64cff0056c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: George King Single Donor Normal Plasma
• Version Model Number: 0001-0.5
• 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: 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: 1-800-255-5108
• Email: plasma@kingbiomed.co
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.co
• Phone: 1-800-255-5108
• Email: plasma@kingbiomed.co

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815696021105 [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: 2018-04-30
• Device Publish Date: 2018-03-30

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