Protect U Guard CPE Isolation Gown

GUDID B086205052

Protect U Guard CPE Isolation Gown

PROTECT U GUARD, LLC

Isolation gown, single-use
Primary Device IDB086205052
NIH Device Record Keya45ba7a0-a061-4b35-a080-c209225048d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameProtect U Guard CPE Isolation Gown
Version Model NumberP10505
Company DUNS080070945
Company NamePROTECT U GUARD, LLC
Device Count15
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone8138150530
Emailsales@protectuguard.com
Phone8138150530
Emailsales@protectuguard.com
Phone8138150530
Emailsales@protectuguard.com
Phone8138150530
Emailsales@protectuguard.com
Phone8138150530
Emailsales@protectuguard.com
Phone8138150530
Emailsales@protectuguard.com
Phone8138150530
Emailsales@protectuguard.com
Phone8138150530
Emailsales@protectuguard.com
Phone8138150530
Emailsales@protectuguard.com
Phone8138150530
Emailsales@protectuguard.com
Phone8138150530
Emailsales@protectuguard.com
Phone8138150530
Emailsales@protectuguard.com
Phone8138150530
Emailsales@protectuguard.com
Phone8138150530
Emailsales@protectuguard.com
Phone8138150530
Emailsales@protectuguard.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB086005050 [Unit of Use]
HIBCCB086105051 [Primary]
HIBCCB086205052 [Package]
Contains: B086105051
Package: CARTON [75 Units]
In Commercial Distribution

FDA Product Code

OEANon-Surgical Isolation Gown

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-10
Device Publish Date2021-02-02

Devices Manufactured by PROTECT U GUARD, LLC

B086205052 - Protect U Guard CPE Isolation Gown2021-02-10Protect U Guard CPE Isolation Gown
B086205052 - Protect U Guard CPE Isolation Gown2021-02-10 Protect U Guard CPE Isolation Gown
B086291002 - Protect U Guard Hydrocolloid Sterile Dressing2020-08-31 Protect U Guard Hydrocolloid Sterile Dressing 5x5cm
B086291012 - Protect U Guard Hydrocolloid Sterile Dressing2020-08-31 Protect U Guard Hydrocolloid Sterile Dressing 10x10cm
B086291022 - Protect U Guard Hydrocolloid Sterile Dressing2020-08-31 Protect U Guard Hydrocolloid Sterile Dressing Sacral 14x18cm
B086291032 - Protect U Guard Hydrocolloid Sterile Dressing2020-08-31 Protect U Guard Hydrocolloid Sterile Dressing Oval/Heel 4x7cm
B086291042 - Protect U Guard Hydrocolloid With Foam Backing Sterile Dressing2020-08-31 Protect U Guard Hydrocolloid With Foam Backing Sterile Dressing 10x10cm
B086291102 - Protect U Guard Alginate Sterile Dressing2020-08-31 Protect U Guard Alginate Sterile Dressing 5x5cm
B086291112 - Protect U Guard Alginate Sterile Dressing2020-08-31 Protect U Guard Alginate Sterile Dressing 10x10cm

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