George King Pooled Normal Plasma

GUDID 00815696020245

George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be used as a normal control for the one-stage prothrombin time assay (PT), the activated partial thromboplastin time (aPTT) assay and the fibrinogen assay. It may also be used as the normal pooled plasma for mixing studies in the determination of a prolonged (PT) and/or aPTT.

GEORGE KING BIO-MEDICAL, INC

Multiple coagulation factor IVD, control

• Primary Device ID: 00815696020245
• NIH Device Record Key: f66c38a5-6261-487c-8bd5-d1db9005a430
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: George King Pooled Normal Plasma
• Version Model Number: 0010-50.0
• 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	00815696020245 [Primary]

FDA Product Code

• GGN: Plasma, Coagulation Control

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: 2016-08-21

On-Brand Devices [George King Pooled Normal Plasma]

• 00815696021044: George King Pooled Normal Plasma is fresh frozen citrated plasma and is intended to be used as a
• 00815696020542: George King Pooled Normal Plasma is fresh frozen citrated plasma and is intended to be used as a
• 00815696020535: George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be use
• 00815696020528: George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be use
• 00815696020290: George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be us
• 00815696020283: George King Pooled Normal Plasma is fresh frozen human citrated plasma and is intended to be use
• 00815696020276: George King Pooled Normal Plasma is fresh frozen citrated human plasma is intended to be used as
• 00815696020245: George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be use
• 00815696020139: George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be use
• 00815696020122: George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be use
• 00815696020115: George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be use
• 00815696020108: George King Pooled Normal Plasma is fresh frozen citrated plasma and is intended to be used as a
• 00815696021198: George King Pooled Normal Plasma is fresh frozen citrated plasma and is intended to be used as a
• 00815696021259: George King Pooled Normal Plasma is fresh frozen citrated human plasma and is intended to be use
• 00815696021297: George King Pooled Normal Plasma is fresh frozen citrated human plasma is intended to be used as