George King Factor IX Deficient Plasma

GUDID 00815696020009

George King Factor IX Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor IX Deficient donors

GEORGE KING BIO-MEDICAL, INC

Coagulation factor IX IVD, reagent

• Primary Device ID: 00815696020009
• NIH Device Record Key: 36885626-7a34-4312-94b3-0f31399ac0c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: George King Factor IX Deficient Plasma
• Version Model Number: 0900-1.0
• 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: 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.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 *-70˚C or below

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815696020009 [Primary]

FDA Product Code

• GJT: Plasma, Coagulation Factor Deficient

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: 2016-07-11

On-Brand Devices [George King Factor IX Deficient Plasma]

• 00815696021013: George King Factor IX Deficient Plasma is fresh frozen citrated human plasma derived from congen
• 00815696021006: George King Factor IX Deficient Plasma is fresh frozen citrated human plasma derived from congen
• 00815696020610: George King Factor IX Deficient Plasma is fresh frozen citrated human plasma derived from congen
• 00815696020306: George King Factor IX Deficient Plasma is fresh frozen citrated human plasma derived from congen
• 00815696020221: George King Factor IX Deficient Plasma is fresh frozen citrated human plasma derived from congen
• 00815696020214: George King Factor IX Deficient Plasma is fresh frozen citrated human plasma derived from congen
• 00815696020009: George King Factor IX Deficient Plasma is fresh frozen citrated human plasma derived from congen