Home GUDID 10860009028811 Essential Safety PPE
Primary DI 10860009028811
Brand Essential Safety PPE
Company Essential Safety Ppe LLC
Model E52-XL
Device description Disposable Medical Isolation Gown, AAMI Level 2, SMS Material, XL
Published 2022-11-23
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 10860009028811 Package GS1 60 In Commercial Distribution 20860009028818 Package GS1 100 In Commercial Distribution 00860009028814 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10860009028811 10860009028811 20860009028818 20860009028818 00860009028814 00860009028814 860009028814 0860009028814
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 117623778 Device count 1 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 true Expiration date on label true 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 00860009028807 Essential Safety PPE E52-L 2022-11-23 00860009028814 Essential Safety PPE E52-XL 2022-11-23 10860009028804 Essential Safety PPE E52-L 2022-11-23
Other Devices Sharing Product Codes#