N/A

GUDID 00000000082716

A hand-held battery-powered electronic instrument designed to measure a patient's body temperature using infrared waves. The device has a infrared probe and an LCD display. It is designed to take a temperature reading in approximately 1 second. This is a reusable device.

180 INNOVATIONS LLC

Infrared patient thermometer, ear

• Primary Device ID: 00000000082716
• NIH Device Record Key: c6f9011c-cb87-4034-97f2-f8d87d4b2788
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: KI-8271
• Company DUNS: 126646582
• Company Name: 180 INNOVATIONS LLC
• 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: true

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00000000082716 [Primary]

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: 2019-05-02
• Device Publish Date: 2019-04-24

On-Brand Devices [N/A]

• 00000000082716: A hand-held battery-powered electronic instrument designed to measure a patient's body temperatu
• 00809148082714: A hand-held battery-powered electronic instrument designed to measure a patient's body temperatu