Hilo Pure

GUDID B904THD2FE0

Digital Forehead Thermometer

HILO INDUSTRIES LLC

Infrared patient thermometer, skin

• Primary Device ID: B904THD2FE0
• NIH Device Record Key: 110391d8-03a9-4ea0-9659-3047871597c9
• Commercial Distribution Discontinuation: 2020-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hilo Pure
• Version Model Number: THD2FE
• Company DUNS: 117472180
• Company Name: HILO INDUSTRIES 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: true
• Lot Batch: false
• 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
HIBCC	B904THD2FE0 [Primary]

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: 2020-06-12
• Device Publish Date: 2020-06-04

Devices Manufactured by HILO INDUSTRIES LLC

• 20810107330207 - Hilo Fit: 2025-01-31 Hilo Fit Isolation Gown, Size LARGE, SINGLE USE ONLY, LEVEL 2 AAMI PB70, Meets requirement of Specification F3352-19. Available
• 20810107330214 - Hilo Fit: 2025-01-31 Hilo Fit Isolation Gown, Size X-LARGE, SINGLE USE ONLY, LEVEL 2 AAMI PB70, Meets requirement of Specification F3352. Available i
• 10810107330293 - Hilo Fit: 2022-09-15 Isolation Gown (raglan sleeves), AAMI Level 3, Model 32704XL, Size XLarge
• 10810107330286 - Hilo Fit: 2022-09-15 Isolation Gown (raglan sleeves), AAMI Level 3, Model 32703L, Size Large
• 10810107330262 - Hilo Fit: 2022-09-15 Isolation Gown (raglan sleeves), AAMI Level 1, Model 12703L, Size Large
• 10810107330279 - Hilo Fit: 2022-09-15 Isolation Gown (raglan sleeves), AAMI Level 1, Model 12704XL, Size XLarge
• 10810107330248 - Hilo Fit: 2022-09-15 Isolation Gown (raglan sleeves), AAMI Level 2, Model 22703L, Size Large
• 10810107330255 - Hilo Fit: 2022-09-15 Isolation Gown (raglan sleeves), AAMI Level 2, Model 22704XL, Size XLarge