Home GUDID B086205052 Protect U Guard CPE Isolation Gown
Primary DI B086205052
Brand Protect U Guard CPE Isolation Gown
Company PROTECT U GUARD, LLC
Model P10505
Device description Protect U Guard CPE Isolation Gown
Published 2021-02-02
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile false
Single use true Product Codes# Code, Name table Code Name OEA Non-Surgical Isolation Gown
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OEA Non-Surgical Gown General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B086205052 Package HIBCC 75 In Commercial Distribution B086105051 Primary HIBCC 0 B086005050 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Isolation gown, single-use A garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.
Regulatory Flags# DUNS number 080070945 Device count 15 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B086191501 Protect U Guard U-Shaped IV Transparent Dressing P19150 2020-08-21 B086191511 Protect U Guard Transparent Sterile Dressing P19151 2020-08-21 B086191541 Protect U Guard Transparent Sterile Dressing PU Incise P19154 2020-08-21 B086202012 Protect U Guard Bouffant Cap Blue P20201 2017-02-24 B086202022 Protect U Guard Bouffant Cap Yellow P20202 2017-02-24 B086203012 Protect U Guard Doctor Cap Blue P20301 2017-02-24 B086191311 Protect U Guard Silicone Foam Sterile Dressing P19131 2020-08-21 B086191321 Protect U Guard Silicone Foam Sterile Dressing P19132 2020-08-21 B086105051 Protect U Guard CPE Isolation Gown P10505 2021-02-02 B086191001 Protect U Guard Hydrocolloid Sterile Dressing P19100 2020-08-21 B086191011 Protect U Guard Hydrocolloid Sterile Dressing P19101 2020-08-21 B086191021 Protect U Guard Hydrocolloid Sterile Dressing P19102 2020-08-21 B086191031 Protect U Guard Hydrocolloid Sterile Dressing P19103 2020-08-21 B086191041 Protect U Guard Hydrocolloid With Foam Backing Sterile Dressing P19104 2020-08-21 B086191101 Protect U Guard Alginate Sterile Dressing P19110 2020-08-21 B086191111 Protect U Guard Alginate Sterile Dressing P19111 2020-08-21 B086191121 Protect U Guard Alginate Sterile Dressing P19112 2020-08-21 B086191231 Protect U Guard Non-Woven Dressing P19123 2020-08-21 B086191241 Protect U Guard Non-Woven Dressing P29124 2020-08-21 B086191401 Protect U Guard Flexible Fabric Adhesive Bandages P19140 2020-08-21
Other Devices Sharing Product Codes# 
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