Tris Buffered Saline 100991

GUDID G0561009910

Bio/Data Corporation

Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD Buffered isotonic saline reagent IVD

• Primary Device ID: G0561009910
• NIH Device Record Key: fd4b828a-403f-4164-ba60-b6e786a2199a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tris Buffered Saline
• Version Model Number: 100991
• Catalog Number: 100991
• 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	G0561009910 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K761172

FDA Product Code

• JPA: System, Multipurpose For In Vitro Coagulation Studies

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
• G0561009910 - Tris Buffered Saline: 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