iHearth

GUDID 10856362005828

IHEALTH LAB INC.

Infrared patient thermometer, skin

• Primary Device ID: 10856362005828
• NIH Device Record Key: e4f4f704-8206-4b45-843e-3d63361b27b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iHearth
• Version Model Number: PT3SBT
• Company DUNS: 054953337
• Company Name: IHEALTH LAB INC.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856362005821 [Primary]
GS1	10856362005828 [Package]; Contains: 00856362005821; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202753

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: 2021-04-22
• Device Publish Date: 2021-04-14

Devices Manufactured by IHEALTH LAB INC.

• 00850044118922 - iHealth: 2025-09-01
• 10856362005149 - iHealth: 2025-03-11
• 10850044118844 - iHealth: 2024-11-26
• 10850044118868 - iHealth: 2024-11-07
• 10850044118783 - iHealth: 2024-10-07
• 10850044118233 - iHealth: 2024-06-05
• 10850044118240 - iHealth: 2024-06-04
• 10850044118424 - iHealth: 2024-06-03