PAR/PAK II 101310

GUDID G0561013101

Bio/Data Corporation

Platelet aggregation study IVD, kit, nephelometry/turbidimetry

• Primary Device ID: G0561013101
• NIH Device Record Key: 4d94280b-f1d3-4adf-a6f5-ec7b79e3301e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PAR/PAK II
• Version Model Number: 101310
• Catalog Number: 101310
• 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	G0561013101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K790769

FDA Product Code

• JOZ: System, Automated Platelet Aggregation

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

Devices Manufactured by Bio/Data Corporation

• G0561076501 - AGG/PAK 5 Combo Kit: 2024-10-09
• G0561003361 - Test Tubes, Macro: 2023-09-07
• G0561009890 - Calcium Chloride: 2023-09-07
• G0561009910 - Tris Buffered Saline: 2023-09-07
• G0561009940 - Sodium Citrate: 2023-09-07
• G0561013751 - Profiler Paper: 2023-09-07
• G0561015211 - Test Tubes, Micro: 2023-09-07
• G0561055981 - Printer Paper: 2023-09-07