iHearth

GUDID 10856362005828

IHEALTH LAB INC.

Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin 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.

• 10850044118257 - iHealth: 2023-09-07
• 10850044118264 - iHealth: 2023-09-07
• 10850044118202 - iHealth: 2023-09-01
• 00850044118083 - iHealth: 2023-08-22
• 10855111003276 - iHealth: 2023-08-22
• 10855111003917 - iHealth: 2023-08-22
• 10856362005057 - iHealth: 2023-08-22
• 10850044118035 - iHealth: 2022-10-10