AccessGUDID - DEVICE: Stronghold PP/PE Isolation Gown (AAMI Level 2)-M (00850037694655)

GUDID

Device Identifier (DI) Information

Brand Name: Stronghold PP/PE Isolation Gown (AAMI Level 2)-M
Version or Model: SC200M
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: The Stronghold Group LLC

Primary DI Number: 00850037694655
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080344373 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35492	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OEA	Non-Surgical Isolation Gown

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 86f73d6f-267e-4302-bfc6-8a6b44b01fc6
Public Version Date: March 28, 2022
Public Version Number: 1
DI Record Publish Date: March 19, 2022