Protect U Guard Isolation Gown 30 GSM Yellow

GUDID B086205022

PROTECT U GUARD, LLC

Isolation gown, single-use

• Primary Device ID: B086205022
• NIH Device Record Key: b29c059e-68de-440c-83c4-580a05a3e42d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Protect U Guard Isolation Gown 30 GSM Yellow
• Version Model Number: P20502
• Company DUNS: 080070945
• Company Name: PROTECT U GUARD, 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: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B086205020 [Unit of Use]
HIBCC	B086205022 [Primary]

FDA Product Code

• OEA: Non-Surgical Isolation Gown

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-02-24

Devices Manufactured by PROTECT U GUARD, LLC

• B086205052 - Protect U Guard CPE Isolation Gown: 2021-02-10 Protect U Guard CPE Isolation Gown
• B086291002 - Protect U Guard Hydrocolloid Sterile Dressing: 2020-08-31 Protect U Guard Hydrocolloid Sterile Dressing 5x5cm
• B086291012 - Protect U Guard Hydrocolloid Sterile Dressing: 2020-08-31 Protect U Guard Hydrocolloid Sterile Dressing 10x10cm
• B086291022 - Protect U Guard Hydrocolloid Sterile Dressing: 2020-08-31 Protect U Guard Hydrocolloid Sterile Dressing Sacral 14x18cm
• B086291032 - Protect U Guard Hydrocolloid Sterile Dressing: 2020-08-31 Protect U Guard Hydrocolloid Sterile Dressing Oval/Heel 4x7cm
• B086291042 - Protect U Guard Hydrocolloid With Foam Backing Sterile Dressing: 2020-08-31 Protect U Guard Hydrocolloid With Foam Backing Sterile Dressing 10x10cm
• B086291102 - Protect U Guard Alginate Sterile Dressing: 2020-08-31 Protect U Guard Alginate Sterile Dressing 5x5cm
• B086291112 - Protect U Guard Alginate Sterile Dressing: 2020-08-31 Protect U Guard Alginate Sterile Dressing 10x10cm