Calcium Chloride 1009989

GUDID G0561009890

Bio/Data Corporation

Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD Calcium chloride coagulation reagent IVD

• Primary Device ID: G0561009890
• NIH Device Record Key: a6ec0a2f-e15e-4250-95ba-c4c2bd32c06a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calcium Chloride
• Version Model Number: 100989
• Catalog Number: 1009989
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G0561009890 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K792563

FDA Product Code

• KQJ: System, Fibrinogen Determination

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: 2023-09-07
• Device Publish Date: 2023-08-30

Devices Manufactured by Bio/Data Corporation

• G0561003361 - Test Tubes, Macro: 2023-09-07
• G0561009890 - Calcium Chloride: 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
• G0561059771 - Stir Bars, Macro: 2023-09-07