Vermax

GUDID 00628678770188

Infrared Forehead Thermometer

Coastalaware Holdings Inc

Infrared patient thermometer, skin

• Primary Device ID: 00628678770188
• NIH Device Record Key: e2149fa1-152c-49ca-bed0-05353ecbc098
• Commercial Distribution Discontinuation: 2023-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vermax
• Version Model Number: PG-IRT1602
• Company DUNS: 204259977
• Company Name: Coastalaware Holdings 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	00628678770188 [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: 2021-10-25
• Device Publish Date: 2021-10-17

On-Brand Devices [Vermax]

• G025PGIRT16020: Infrared Forehead Thermometer.
• 00628678770188: Infrared Forehead Thermometer