Amazrock

GUDID 08883000001749

AMAZROCK Digital Infrared Thermometer Dual Mode supports temperature scan via Forehead or Eardrum Detection. It is designed for use with adults and children. Modern Design & Convenient to Use - Ergonometric design to facilitate easy use across all ages. - The back-light screen makes it very convenient to use at night or under dim lighting conditions. - Rapid and accurate reading with 1 second measurement time. - Forehead scan mode makes it convenient to measure temperature while your child is sleeping. - Eardrum temperature detection mode is only suitable for use for ages 3 months & above. - Easy & Comfortable use experience as compared with other thermometer(s). Simple operations with just 2 buttons - “Head” (Forehead temperature detection) or “Ear” (Eardrum temperature scan). - Supports 20 readings memory recall. - Comes with two AAA batteries for immediate use.

AMAZROCK PTE. LTD.

Infrared patient thermometer, skin

• Primary Device ID: 08883000001749
• NIH Device Record Key: c7161f12-33e3-4a1c-8c88-d9156a8168f8
• Commercial Distribution Discontinuation: 2018-04-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Amazrock
• Version Model Number: Amaz-HC1001401
• Company DUNS: 659258748
• Company Name: AMAZROCK PTE. LTD.
• 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: false
• Serial Number: true
• 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	08883000001749 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131243

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-12-04
• Device Publish Date: 2017-06-30