SPIFE Nexus Dispo Stain Cups

GUDID M52525750000

HELENA LABORATORIES CORPORATION

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• Primary Device ID: M52525750000
• NIH Device Record Key: f746eaf0-b3cf-4c10-bbdb-9cb6e8751ae2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPIFE Nexus Dispo Stain Cups
• Version Model Number: 2575000
• Company DUNS: 079396131
• Company Name: HELENA LABORATORIES CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M52525750000 [Primary]

FDA Product Code

• LXG: Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

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: 2022-06-09
• Device Publish Date: 2022-06-01

Devices Manufactured by HELENA LABORATORIES CORPORATION

• M52518360 - V8 Urine Preparation Buffer: 2023-09-18
• 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