George King Factor VIII Deficient Plasma with Inhibitor

GUDID 00815696020733

George King Factor VIII Deficient plasma with Inhibitor is fresh frozen citrated human plasma derived from a congenital Factor VIII deficient donor who has developed an antibody to FVIII.

GEORGE KING BIO-MEDICAL, INC

Coagulation factor VIII inhibitor IVD, control Coagulation factor VIII inhibitor IVD, control Coagulation factor VIII inhibitor IVD, control

• Primary Device ID: 00815696020733
• NIH Device Record Key: c3767be5-8439-48da-9edf-7aed5299b04e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: George King Factor VIII Deficient Plasma with Inhibitor
• Version Model Number: 1800-1.5
• 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.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	00815696020733 [Primary]

FDA Product Code

• GGC: Control, Plasma, Abnormal

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: 2016-08-18

On-Brand Devices [George King Factor VIII Deficient Plasma with Inhibitor]

• 00815696020733: George King Factor VIII Deficient plasma with Inhibitor is fresh frozen citrated human plasma de
• 00815696020627: George King Factor VIII Deficient plasma with Inhibitor is fresh frozen citrated human plasma de
• 00815696021181: George King Factor VIII Deficient Plasma with Inhibitor is fresh frozen citrated human plasma de
• 00815696021174: George King Factor VIII Deficient Plasma with Inhibitor is fresh frozen citrated human plasma de
• 00815696021167: George King Factor VIII Deficient Plasma with Inhibitor is fresh frozen citrated human plasma de