AccessGUDID - DEVICE: Isolation Gown EasyRelease (00634916790511)

GUDID

Device Identifier (DI) Information

Brand Name: Isolation Gown EasyRelease
Version or Model: 661Y2635
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: STANDARD TEXTILE CO., INC.

Primary DI Number: 00634916790511
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006999858 *Terms of Use

Device Description: Isolation Gown EasyRelease, AAMI Level 1, generic polyester, Yellow, Large, Velcro Hook & Loop Closures at Neck/Waist, Long Sleeves with Natural White Non-Linting Cuffs and Cuff Shields

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":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
35452	Isolation gown, reusable	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 reusable garment intended to be laundered after each use.	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: 8a2b9d29-fee5-4160-9f60-4694c3597b60
Public Version Date: August 08, 2022
Public Version Number: 1
DI Record Publish Date: July 29, 2022