ColoScreen

GUDID M5255515650

HELENA LABORATORIES CORPORATION

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• Primary Device ID: M5255515650
• NIH Device Record Key: 05316077-faec-4bb9-82e3-68138d7378b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ColoScreen
• Version Model Number: 551565
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M5255515650 [Primary]

FDA Product Code

• KHE: REAGENT, OCCULT BLOOD

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-11-28
• Device Publish Date: 2016-09-07

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