HOMEDICS

GUDID 10031262101249

Infrared Ear/Forehead Thermometer

HOMEDICS USA, LLC

Infrared patient thermometer, ear/skin

• Primary Device ID: 10031262101249
• NIH Device Record Key: a18bdb33-745d-4855-ad3c-db69152ca3c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HOMEDICS
• Version Model Number: TIE-300-WT
• Company DUNS: 164414364
• Company Name: HOMEDICS USA, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00031262101242 [Primary]
GS1	10031262101249 [Package]; Contains: 00031262101242; Package: Case [6 Units]; In Commercial Distribution
GS1	40031262101240 [Package]; Contains: 00031262101242; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182597

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: 2021-04-09
• Device Publish Date: 2021-04-01

On-Brand Devices [HOMEDICS]

• 00031262099280: Pulse Oximeter
• 10031262101249: Infrared Ear/Forehead Thermometer
• 10031262101737: PILLOW WITH REMOVEABLE GEL