Tris-Buffered Saline

GUDID M52553650

HELENA LABORATORIES CORPORATION

Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD Buffered sample diluent IVD

• Primary Device ID: M52553650
• NIH Device Record Key: 4a39ef78-8fad-459f-af9c-38fcf47e0336
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tris-Buffered Saline
• Version Model Number: 5365
• Company DUNS: 079396131
• Company Name: HELENA LABORATORIES 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

Customer Support Contacts

• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com
• Phone: +1(800)231-5663
• Email: helena@helena.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M52553650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K840329

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-11
• Device Publish Date: 2016-09-07

Devices Manufactured by HELENA LABORATORIES CORPORATION

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• M5255526930 - SPIFE Nexus Split Beta SPE - 80, 100 Gel Kit: 2023-09-18
• M52510680010 - SPIFE Touch, CSA 2015 (120V): 2023-09-11
• M52510690000 - SPIFE Touch (230V): 2023-09-11
• M52510880010 - SPIFE 3000 w/ New Pump & Valve (110V): 2023-09-11
• M52510880020 - SPIFE 3000, "CE 2011" (120V): 2023-09-11
• M52510890010 - SPIFE 3000 w/ New Pump & Valve (220V): 2023-09-11
• M52510890020 - SPIFE 3000, "CE 2011" (230V): 2023-09-11