Lyophilized Platelets 101258

GUDID G0561012580

Bio/Data Corporation

von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent

• Primary Device ID: G0561012580
• NIH Device Record Key: 1bdce171-a8e1-453c-9fe7-4fc14f0bed0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lyophilized Platelets
• Version Model Number: 10mL
• Catalog Number: 101258
• Company DUNS: 051392959
• Company Name: Bio/Data Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G0561012580 [Primary]

FDA Product Code

• GGP: Test, Qualitative And Quantitative Factor Deficiency

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: 2022-03-31
• Device Publish Date: 2022-03-23

On-Brand Devices [Lyophilized Platelets ]

• G0561015951: 3 X 4.0 mL
• G0561012580: 10mL