paramed

GUDID 00856324008297

This device used to measure human temparature

SILEX GLOBAL LLC

Infrared patient thermometer, ear/skin

• Primary Device ID: 00856324008297
• NIH Device Record Key: 812109ff-6a70-4174-a719-0bbd93bf63dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: paramed
• Version Model Number: Infrared ear/forehead thermometer PG-IRT1603
• Company DUNS: 081135914
• Company Name: SILEX GLOBAL 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: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-307-212-8504
• Email: silexglobal@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856324008297 [Primary]

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: 2020-06-29
• Device Publish Date: 2020-06-19

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