Hilo Fit

GUDID 10810107330408

Isolation Gown, AAMI Level 2, Model 21004XL, Size XLarge

Hilo Industries LLC

Isolation gown, single-use

• Primary Device ID: 10810107330408
• NIH Device Record Key: 70af6e55-4883-48b8-83d6-766398535f94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hilo Fit
• Version Model Number: 21004XL
• Company DUNS: 117472180
• Company Name: Hilo Industries LLC
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810107330418 [Primary]
GS1	10810107330408 [Unit of Use]

FDA Product Code

• OEA: Non-Surgical Isolation Gown

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: 2022-09-15
• Device Publish Date: 2022-09-07

On-Brand Devices [Hilo Fit]

• 10810107330217: Hilo Fit Isolation Gown, Size X-LARGE, SINGLE USE ONLY, LEVEL 2 AAMI PB70, Meets requirement of
• 10810107330200: Hilo Fit Isolation Gown, Size LARGE, SINGLE USE ONLY, LEVEL 2 AAMI PB70, Meets requirement of Sp
• 00810107330234: Hilo Fit Isolation Gown, Size X-LARGE, SINGLE USE ONLY, LEVEL 2 AAMI PB70, Meets requirement of
• 00810107330227: Hilo Fit Isolation Gown, Size LARGE, SINGLE USE ONLY, LEVEL 2 AAMI PB70, Meets requirement of Sp
• 10810107330460: Isolation Gown, AAMI Level 3, Model 31004XL, Size XLarge
• 10810107330422: Isolation Gown, AAMI Level 2, Model 21003L, Size Large
• 10810107330439: Isolation Gown, AAMI Level 3, Model 31003L, Size Large
• 10810107330408: Isolation Gown, AAMI Level 2, Model 21004XL, Size XLarge
• 10810107330385: Isolation Gown, AAMI Level 1, Model 11004XL, Size XLarge
• 10810107330361: Isolation Gown, AAMI Level 1, Model 11003L, Size Large
• 10810107330255: Isolation Gown (raglan sleeves), AAMI Level 2, Model 22704XL, Size XLarge
• 10810107330248: Isolation Gown (raglan sleeves), AAMI Level 2, Model 22703L, Size Large
• 10810107330279: Isolation Gown (raglan sleeves), AAMI Level 1, Model 12704XL, Size XLarge
• 10810107330262: Isolation Gown (raglan sleeves), AAMI Level 1, Model 12703L, Size Large
• 10810107330286: Isolation Gown (raglan sleeves), AAMI Level 3, Model 32703L, Size Large
• 10810107330293: Isolation Gown (raglan sleeves), AAMI Level 3, Model 32704XL, Size XLarge
• 20810107330214: Hilo Fit Isolation Gown, Size X-LARGE, SINGLE USE ONLY, LEVEL 2 AAMI PB70, Meets requirement of
• 20810107330207: Hilo Fit Isolation Gown, Size LARGE, SINGLE USE ONLY, LEVEL 2 AAMI PB70, Meets requirement of Sp