CVS Health

GUDID 40504280825158

A hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature from the inner ear. The device has an infrared probe and an LCD display. It is designed to take a temperature reading in approximately 2 seconds. This is a reuseable device.

WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Infrared patient thermometer, ear

• Primary Device ID: 40504280825158
• NIH Device Record Key: 7ab7b82f-4fad-454c-b76f-048c689d5684
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CVS Health
• Version Model Number: HTD8220
• Company DUNS: 062312574
• Company Name: WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
• 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: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 303-271-0300
• Email: info@180innovations.com
• Phone: 303-271-0300
• Email: info@180innovations.com
• Phone: 303-271-0300
• Email: info@180innovations.com
• Phone: 303-271-0300
• Email: info@180innovations.com
• Phone: 303-271-0300
• Email: info@180innovations.com
• Phone: 303-271-0300
• Email: info@180innovations.com
• Phone: 303-271-0300
• Email: info@180innovations.com
• Phone: 303-271-0300
• Email: info@180innovations.com
• Phone: 303-271-0300
• Email: info@180innovations.com
• Phone: 303-271-0300
• Email: info@180innovations.com
• Phone: 303-271-0300
• Email: info@180innovations.com
• Phone: 303-271-0300
• Email: info@180innovations.com
• Phone: 303-271-0300
• Email: info@180innovations.com
• Phone: 303-271-0300
• Email: info@180innovations.com
• Phone: 303-271-0300
• Email: info@180innovations.com
• Phone: 303-271-0300
• Email: info@180innovations.com
• Phone: 303-271-0300
• Email: info@180innovations.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00050428082515 [Primary]
GS1	40504280825158 [Package]; Contains: 00050428082515; Package: case [72 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180387

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

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: 2023-12-26
• Device Publish Date: 2023-12-18

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