Surelife ThinTemp

GUDID MHC18601062

Surelife ThinTemp Thermometer

MHC MEDICAL PRODUCTS, LLC

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: MHC18601062
• NIH Device Record Key: ef5d9e41-2fd1-49f1-aa72-d81f29415cac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surelife ThinTemp
• Version Model Number: 860106
• Company DUNS: 169895245
• Company Name: MHC MEDICAL PRODUCTS, 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: true
• Expiration Date: true
• 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
HIBCC	MHC18601062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180207

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: 2021-03-17
• Device Publish Date: 2021-03-09

Devices Manufactured by MHC MEDICAL PRODUCTS, LLC

• MHC18090112 - HealthPro: 2023-04-27 Healthpro Control Solution
• MHC18020241 - EasyTouch: 2022-05-12 ET 20mL Luer Lock Barrel Only (TB)
• MHC18020641 - EasyTouch: 2022-05-12 ET 60mL Luer Lock Barrel Only (TB)
• MHC18070022 - EasyTouch: 2022-05-12 ET Glucose Meter Only
• MHC18152001 - EasyTouch: 2022-05-12 ET 25G 5/8 in Fluringe (FlipLock Needle Only)
• MHC18152011 - EasyTouch: 2022-05-12 ET 25G 1 in Fluringe (FlipLock Needle Only)
• MHC18223211 - EasyTouch: 2022-05-12 ET 23G 1 in 1mL Low Dead Space FlipLock Syr
• MHC18223611 - EasyTouch: 2022-05-12 ET 23G 1 in 3mL Low Dead Space FlipLock Syr