Home GUDID 00850037694686 Stronghold PP/PE Isolation Gown (AAMI Level 2)-Unisize
Primary DI 00850037694686
Brand Stronghold PP/PE Isolation Gown (AAMI Level 2)-Unisize
Company The Stronghold Group LLC
Model SC200U
Device description This gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate materials. Not intended for use in the operating room. This gown is classified as Level 2 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. Pack of 10.
Published 2022-03-19
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
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 00850037694723 Package GS1 10 In Commercial Distribution 00850037694686 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 00850037694723 00850037694723 850037694723 0850037694723 00850037694686 00850037694686 850037694686 0850037694686
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 080344373 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850037694648 Stronghold PP/PE Isolation Gown (AAMI Level 2)-S SC200S 2022-03-19 00850037694655 Stronghold PP/PE Isolation Gown (AAMI Level 2)-M SC200M 2022-03-19 00850037694662 Stronghold PP/PE Isolation Gown (AAMI Level 2)-L SC200L 2022-03-19 00850037694679 Stronghold PP/PE Isolation Gown (AAMI Level 2)-XL SC200XL 2022-03-19 00850037694730 Stronghold SMS Isolation Gown (AAMI Level 2)-S SC210S 2022-03-19 00850037694747 Stronghold SMS Isolation Gown (AAMI Level 2)-M SC210M 2022-03-19 00850037694754 Stronghold SMS Isolation Gown (AAMI Level 2)-L SC210L 2022-03-19 00850037694761 Stronghold SMS Isolation Gown (AAMI Level 2)-XL SC210XL 2022-03-19 00850037694778 Stronghold SMS Isolation Gown (AAMI Level 2)-Unisize SC210U 2022-03-19 10850037694645 Stronghold PP/PE Isolation Gown (AAMI Level 2)-S SC200S 2022-03-19 00850037694693 Stronghold PP/PE Isolation Gown (AAMI Level 2)-M SC200M 2022-03-19 00850037694709 Stronghold PP/PE Isolation Gown (AAMI Level 2)-L SC200L 2022-03-19 00850037694716 Stronghold PP/PE Isolation Gown (AAMI Level 2)-XL SC200XL 2022-03-19 00850037694723 Stronghold PP/PE Isolation Gown (AAMI Level 2)-Unisize SC200U 2022-03-19 00850037694785 Stronghold SMS Isolation Gown (AAMI Level 2)-S SC210S 2022-03-19 00850037694792 Stronghold SMS Isolation Gown (AAMI Level 2)-M SC210M 2022-03-19 00850037694808 Stronghold SMS Isolation Gown (AAMI Level 2)-L SC210L 2022-03-19 00850037694815 Stronghold SMS Isolation Gown (AAMI Level 2)-XL SC210XL 2022-03-19 00850037694822 Stronghold SMS Isolation Gown (AAMI Level 2)-Unisize SC210U 2022-03-19 00860007372209 Stronghold Group Nitrile Examination Glove, Powder Free-S SHFBSNS0603S 2022-03-08
Other Devices Sharing Product Codes#