George King Factor XI Deficient Plasma

GUDID 00815696020078

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

GEORGE KING BIO-MEDICAL, INC

Coagulation factor XI IVD, reagent

• Primary Device ID: 00815696020078
• NIH Device Record Key: fbaf85d1-4278-4787-8717-05889d3829dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: George King Factor XI Deficient Plasma
• Version Model Number: 1100-1.0
• 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	00815696020078 [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: 2016-08-22

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

• 00815696021020: George King Factor XI Deficient Plasma is fresh frozen citrated human plasma derived from congen
• 00815696020825: George King Factor XI Deficient Plasma is fresh frozen citrated human plasma derived from congen
• 00815696020818: George King Factor XI Deficient Plasma is fresh frozen citrated human plasma derived from congen
• 00815696020801: George King Factor XI Deficient Plasma is fresh frozen citrated human plasma derived from congen
• 00815696020795: George King Factor XI Deficient Plasma is fresh frozen citrated human plasma derived from congen
• 00815696020252: George King Factor XI Deficient Plasma is fresh frozen citrated human plasma derived from congen
• 00815696020078: George King Factor XI Deficient Plasma is fresh frozen citrated human plasma derived from congen