Actalyke Thermometer

GUDID M52557570000

HELENA LABORATORIES CORPORATION

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• Primary Device ID: M52557570000
• NIH Device Record Key: a9a5ee35-70b1-43b1-9174-3a22878e932a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Actalyke Thermometer
• Version Model Number: 5757000
• Company DUNS: 836287433
• 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: false
• Lot Batch: false
• Serial Number: true
• 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
• 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	M52557570000 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-09-11
• Device Publish Date: 2017-03-17

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