Protect U Guard CPE Isolation Gown

GUDID B086205052

Protect U Guard CPE Isolation Gown

PROTECT U GUARD, LLC

Isolation gown, single-use

• Primary Device ID: B086205052
• NIH Device Record Key: a45ba7a0-a061-4b35-a080-c209225048d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Protect U Guard CPE Isolation Gown
• Version Model Number: P10505
• Company DUNS: 080070945
• Company Name: PROTECT U GUARD, LLC
• Device Count: 15
• 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: false
• 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

Customer Support Contacts

• Phone: 8138150530
• Email: sales@protectuguard.com
• Phone: 8138150530
• Email: sales@protectuguard.com
• Phone: 8138150530
• Email: sales@protectuguard.com
• Phone: 8138150530
• Email: sales@protectuguard.com
• Phone: 8138150530
• Email: sales@protectuguard.com
• Phone: 8138150530
• Email: sales@protectuguard.com
• Phone: 8138150530
• Email: sales@protectuguard.com
• Phone: 8138150530
• Email: sales@protectuguard.com
• Phone: 8138150530
• Email: sales@protectuguard.com
• Phone: 8138150530
• Email: sales@protectuguard.com
• Phone: 8138150530
• Email: sales@protectuguard.com
• Phone: 8138150530
• Email: sales@protectuguard.com
• Phone: 8138150530
• Email: sales@protectuguard.com
• Phone: 8138150530
• Email: sales@protectuguard.com
• Phone: 8138150530
• Email: sales@protectuguard.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B086005050 [Unit of Use]
HIBCC	B086105051 [Primary]
HIBCC	B086205052 [Package]; Contains: B086105051; Package: CARTON [75 Units]; In Commercial Distribution

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: 2021-02-10
• Device Publish Date: 2021-02-02

Devices Manufactured by PROTECT U GUARD, LLC

• B086205052 - Protect U Guard CPE Isolation Gown: 2021-02-10Protect U Guard CPE Isolation Gown
• 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